FDA 510(k) Applications for Medical Device:
Transmitters And Receivers, Physiological Signal, Radiofrequency
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101834 | 3M COMPANY |
3M CENTER, BLDG. 275-05-W-06 | ST. PAUL | MN | 55144-1000 |
| K120704 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55133-3275 |
| K122333 | AFRAME DIGITAL, INC. |
1889 PRESTON WHITE DR STE 101 | Reston | VA | 20191 |
| K092635 | ALCATEL-LUCENT CANADA INC. |
1380 RODICK RD. | MARKHAM, ON | L3R 4G5 | |
| K223073 | Alio, Inc. |
10901 W. 120th Ave, Suite 380 | Broomfield | CO | 80021 |
| K993550 | AMERICAN TELECARE, INC. |
7640 GOLDEN TRIANGLE DR. | EDEN PRAIRIE | MN | 55344-3732 |
| K981533 | AMERICAN TELECARE, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K973873 | AMERICAN TELECARE, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K030222 | AMERICAN TELECARE, INC. |
7640 GOLDEN TRIANGLE DR. | EDEN PRAIRIE | MN | 55344-3732 |
| K964554 | AMERICAN TELECARE, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K130676 | ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH |
1266 EAST MAIN STREET | STAMFORD | CT | 06902 |
| K103643 | ASCOT TECHNOLOGIES, INC. |
267 HOGANS VALLEY WAY | CARY | NC | 27513 |
| K081499 | BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
BERNHAEUSER STRASSE 17 | NEUHAUSEN A.D.F. | 73765 | |
| K191614 | BioIntelliSense Inc. |
570 El Camino Real, Suite 200 | Redwood City | CA | 94063 |
| K212957 | BiolntelliSense Inc. |
570 El Camino Real, Suite 200 | Redwood City | CA | 94063 |
| K101078 | BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 | FOXBORO | MA | 02035 |
| K051470 | BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 | FOXBORO | MA | 02035 |
| K113493 | BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 | FOXBORO | MA | 02035 |
| K052608 | BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 | FOXBORO | MA | 02035 |
| K170204 | Boston Scientific Corporation |
47215 Lakeview Blvd. | Fremont | CA | 94538 |
| K072008 | BRAEMAR, INC. |
1285 CORPORATE CENTER DR. | EAGAN | MN | 55121 |
| K191331 | BraveHeart Wireless, Inc. |
11 Perimeter Road | Nashua | NH | 03063 |
| K002514 | CADUCEUS HEALTH CARE LTD. |
1809 BARRINGTON ST. STE 708 | HALIFAX NS | B3J 3K8 | |
| K122285 | CARDIOCOM LLC |
7980 CENTURY BLVD. | CHANHASSEN | MN | 55317 |
| K150289 | CARDIOLINE S.p.A |
Via De Zinis, 6 | CAVARENO | TN | 38011 |
| K220526 | Cardioline S.P.A |
Via Linz 151 | Trento | 38121 | |
| K110809 | CAREFUSION 303, INC. |
115 MITON PARK | ABINGDON,OXON | OX 14 4RZ | |
| K073038 | CAREMATIX INC. |
120 S. RIVERSIDE PLAZA | CHICAGO | IL | 60606 |
| K100508 | CAREMATIX INC. |
209 W. JACKSON BLVD. | CHICAGO | IL | 60606 |
| K040966 | CAREMATIX INC. |
2 N. LASALLE ST. | CHICAGO | IL | 60602 |
| K181196 | Caretaker Medical, LLC |
941 Glenwood Station Ln, Suite 301 | Charlottesville | VA | 22901 |
| K134004 | CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS |
ONE VERIZON WAY | BASKING RIDGE | NJ | 07920 |
| K122458 | CELLO PARTNERSHIP D/B/A VERIZON WIRELESS |
1300 I ST NW, SUITE 400 W | WASHINGTON | DC | 20005 |
| K093134 | CERNER CORP. |
2800 ROCKCREEK PKWY. | KANSAS CITY | MO | 64117 |
| K181248 | Comarch Healthcare SA |
al. Jana Pawla II 39a, | Krakow | 31-864 | |
| K062215 | CONFIDANT INC. |
2530 MERIDIAN PARKWAY | DURHAM | NC | 27713 |
| K072698 | CONFIDANT INC. |
2530 MERIDIAN PARKWAY | DURHAM | NC | 27713 |
| K083331 | CONFIDANT INC. |
2530 MERIDIAN PARKWAY | DURHAM | NC | 27713 |
| K120941 | CONSTANT CARE, LLC |
1300 I ST, NW, 11TH FLOOR EAST | WASHINGTON | DC | 20005-3314 |
| K130360 | CONSTANT CARE, LLC |
1300 I ST, NW, 11TH FLOOR EAST | WASHINGTON | DC | 20005-3314 |
| K093895 | CONTINUITY HEALTH SOLUTIONS |
850 NORTH 25TH STREET | OZARK | MO | 65721 |
| K000276 | CRITICARE SYSTEMS, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K091430 | DIGIO2 INTERNATIONAL CO., LTD |
2904 N BOLDT DRIVE | FLAGSTAFF | AZ | 86001 |
| K211822 | Elastic Care Incorporated |
95 Apple Creek Blvd. | Markham | L3R 1C7 | |
| K120253 | ELCAM MEDICAL A.C.A.L. |
KIBBUTZ BAR-AM | D.N. MEROM HAGALIL | 13860 | |
| K122095 | Emergo Europe Consulting BV |
PRINSESSEGRACHT 20 | DEN HAAG | 2514 | |
| K132930 | ENTRA HEALTH SYSTEMS |
3111 Camino Del Rio North | San Diego | CA | 92108 |
| K212883 | ergoline GmbH |
Lindenstrasse 5 | Bitz | 72475 | |
| K090801 | EXPRESS MD SOLUTIONS, LLC |
2001 BOMER DRIVE | PALM BEACH GARDENS | FL | 33418 |
| K013533 | GENERAL DEVICES |
1000 RIVER ST. | RIDGEFIELD | NJ | 07657 |
| K002089 | GENERAL DEVICES |
1000 RIVER ST. | RIDGEFIELD | NJ | 07657 |
| K030795 | GMP/COMPANIES, INC. |
ONE EAST BROWARD BLVD. | FORT LAUDERDALE | FL | 33301 |
| K211365 | Graftworx, Inc. dba Alio |
544B Bryant Street | San Francisco | CA | 94107 |
| K050567 | HEALTH HERO NETWORK, INC. |
2570 WEST EL CAMINO REAL | MOUNTAIN VIEW | CA | 94040-1309 |
| K063612 | HEALTH HERO NETWORK, INC. |
2000 SEAPORT BLVD, SUITE 400 | REDWOOD CITY | CA | 94063 |
| K070543 | HEALTH HERO NETWORK, INC. |
2000 SEAPORT BLVD, SUITE 400 | REDWOOD CITY | CA | 94063 |
| K080091 | HEALTH HERO NETWORK, INC. |
2400 GENG ROAD | PALO ALTO | CA | 94303 |
| K091220 | HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY |
515 LEGGET DRIVE SUITE 700 | OTTAWA | K2K 3G4 | |
| K133252 | HEALTHINTERLINK, LLC |
55 NORTHERN BLVD, STE. 200 | GREAT NECK | NY | 11021 |
| K993169 | HEWLETT-PACKARD CO. |
2081 LONGDEN CIRCLE | LOS ALTOS | CA | 94024 |
| K172011 | HMicro, Inc. |
39355 California Street, #303 | Fremont | CA | 94538 |
| K141792 | HONEYWELL HOMMED |
3400 INTERTECH DRIVE | BROOKFIELD | WI | 53045 |
| K101242 | HONEYWELL HOMMED, LLC |
3400 INTERTECH DR. | BROOKFIELD | WI | 53045 |
| K061087 | HONEYWELL HOMMED, LLC |
2018 NORTH DURHAM DRIVE | HOUSTON | TX | 77008 |
| K112858 | HONEYWELL HOMMED, LLC |
3400 INTERTECH DR. | BROOKFIELD | WI | 53045 |
| K153719 | HONEYWELL HOMMED, LLC |
3400 INTERTECH DR. | BROOKFIELD | WI | 53045 |
| K061088 | HONEYWELL HOMMED, LLC |
2018 NORTH DURHAM DRIVE | HOUSTON | TX | 77008 |
| K090610 | HOSPIRA, INC. |
275 NORTH FIELD DR. | LAKE FOREST | IL | 60045 |
| K091021 | IMETRIKUS, INC. |
2141 LANDINGS DRIVE | MOUNTAIN VIEW | CA | 94043 |
| K080798 | INTEL CORP. |
1900 PRAIRIE CITY RD., FM7-197 | FOLSOM | CA | 95630 |
| K101178 | INTEL CORP. |
1900 PRAIRIE CITY RD., FM7-197 | FOLSOM | CA | 95630 |
| K083115 | INTEL CORP. |
1900 PRAIRIE CITY RD., FM7-197 | FOLSOM | CA | 95630 |
| K103276 | INTEL CORPORATION DIGITAL HEALTH GROUP |
1900 PRAIRIE CITY ROAD | Folsom | CA | 95630 |
| K130821 | INTEL-GE CARE INNOVATIONS LLC |
3721 DOUGLAS BOULEVARD | ROSEVILLE | CA | 95661 |
| K130290 | INTEL-GE CARE INNOVATIONS LLC |
3721 DOUGLAS BOULEVARD | ROSEVILLE | CA | 95661 |
| K063484 | INTERMED ADVISORS, INC. |
828 MASSACHUSETTS AVENUE | ARLINGTON | MA | 02476 |
| K120895 | INTOUCH HEALTH, INC. |
6330 HOLLISTER AVE. | GOLETA | CA | 93117 |
| K123229 | INTOUCH HEALTH, INC. |
6330 HOLLISTER AVE. | GOLETA | CA | 93117 |
| K073710 | INTOUCH TECHNOLOGIES |
90 CASTILIAN DRIVE | GOLETA | CA | 93117 |
| K172329 | Isansys Lifecare Ltd |
8C Park Square | Oxford | OX14 4RR | |
| K133997 | LG ELECTRONICS |
816 CONGRESS AVE. #1400 | AUSTIN | TX | 78701 |
| K103214 | LIFELINE SYSTEMS, INC. |
111 LAWRENCE ST. | FRAMINGHAM | MA | 01702-8156 |
| K200690 | LifeSignals, Inc. |
39355 California Street, Suite 305 | Fremont | CA | 94538 |
| K202868 | LifeSignals, Inc. |
39355 California Street, Suite 305 | Fremont | CA | 94538 |
| K171188 | LR Med Inc |
1450, Tomlin Drive Burr Ridge | Burr Ridge | IL | 60527 |
| K173510 | MC10 Inc. |
10 Maguire Road Bldg 3 First Floor | Lexington | MA | 02421 |
| K124000 | MEDAPPS INC., DBA ALERE CONNECT |
8767 E. VIA DE VENTURA, STE 300 | SCOTTSDALE | AZ | 85258 |
| K132803 | MEDAPPS INC., DBA ALERE CONNECT |
8767 E. VIA DE VENTURA, STE 300 | SCOTTSDALE | AZ | 85258 |
| K083862 | MEDAPPS, INC. |
7975 NORTH HAYDEN ROAD | SCOTTSDALE | AZ | 85258 |
| K112559 | MEDAPPS, INC. |
7975 NORTH HAYDEN ROAD | SCOTTSDALE | AZ | 85258 |
| K061502 | MEDIC4ALL (ISRAEL) LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K062127 | MEDIC4ALL (ISRAEL) LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K062662 | MEDIC4ALL (ISRAEL) LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K061606 | MEDICAL DEVICES/PADPRO, INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K091696 | MEDICOMP, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K161916 | MEDICOMP, INC. |
600 ATLANTIS RD | MELBOURNE | FL | 32904 |
| K040663 | MOLEX, INC. |
P.O. BOX 53142 | CHICAGO | IL | 60653 |
| K182297 | Mortara Instrument Inc |
7865 North 86th Street | Milwaukee | WI | 53224 |
| K974149 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K141020 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K022274 | NEPTEC DESIGN GROUP, LTD. |
302 LEGGET DR. | KANATA ONTARIO | K2K 1Y5 | |
| K071058 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K102106 | NIHON KOHDEN CORP. |
90 ICON STREET | FOOTHILL | CA | 92610 |
| K130971 | OPTUMHEALTH CARE SOLUTIONS, INC. |
4 INNOVATION DR | DUNDAS, ON | L9H 7P3 | |
| K050929 | PALAISTRA SYSTEMS INC. |
408 19TH STREET SW | ROCHESTER | MN | 55902 |
| K071564 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K192875 | Philips Medical Systems |
2 Canal Park | Cambridge | MA | 02141 |
| K023749 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K052961 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K131913 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BOEBLINGEN, BW | D-71034 | |
| K100524 | POLYMAP WIRELESS, LLC |
310 S. WILLIAMS BLVD. STE.350 | TUCSON | AZ | 85711 |
| K163694 | Rooti Labs Ltd. |
5F-1, No.17, Zhouzi St., Neihu Dist. | Taipei | 11493 | |
| K062304 | RTX HEALTHCARE A/S |
STROEMMEN 6 | NOERRESUNDBY | DK-9400 | |
| K041816 | RTX HEALTHCARE A/S |
STROEMMEN 6 | NOERRESUNDBY | DK-9400 | |
| K071953 | RTX HEALTHCARE A/S |
STROEMMEN 6 | NOERRESUNDBY | DK-9400 | |
| K132148 | SAMSUNG ELECTRONICS CO., LTD. |
129, SAMSUNG-RO, | SUWON-SI, GYEONGGI-DO | 443-742 | |
| K132173 | SANITAS, INC. |
11440 W. BERNARDO COURT, STE 300 | SAN DIEGO | CA | 92027 |
| K123671 | SANITAS, INC. |
11440 W. BERNARDO COURT, STE 300 | SAN DIEGO | CA | 92127 |
| K050778 | SCOTTCARE |
4791 WEST 150TH ST. | CLEVELAND | OH | 44135 |
| K223711 | Sibel Health Inc. |
6650 W Touhy Ave. | Niles | IL | 60714 |
| K211305 | Sibel Inc. |
6650 W Touhy Ave | Niles | IL | 60714 |
| K221530 | Sibel Inc. |
6650 W. Touhy Ave. | Niles | IL | 60714 |
| K213233 | Sigknow Biomedical Co.,Ltd. |
6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, | Taipei City | 105412 | |
| K111854 | ST. JUDE MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 | UPPSALA | SE-751 35 | |
| K133587 | ST. JUDE MEDICAL SYSTEMS AB |
4 ROBBINS RD. | WESTFORD | MA | 01886 |
| K171019 | Synergen Technology Labs LLC |
3131 McKinney Avenue | Dallas | TX | 75204 |
| K100427 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 24888 | |
| K083046 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 241 | |
| K103796 | TELEMEDCARE PTY LTD |
UNIT 7, 6-8 CREWE PLACE | ROSEBERY, NEW SOUTH WALES | 2018 | |
| K050128 | TELEVITAL, INC. |
409 WALNUT STREET | SAN CARLOS | CA | 94070 |
| K090886 | TUNSTALL HEALTHCARE |
STROEMMEN 6 | NOERRESUNDBY | DK-9400 | |
| K171406 | United Health Group Inc. |
1100 King Street, Buliding 6, Suite 300 | Rye Brook | NY | 10573 |
| K113446 | VIGNET INC. |
7833 KNOLLBROOK DR. | PLEASANTON | CA | 94588 |
| K171029 | Visicu Inc. |
217 East Redwood St. Suite 1900 | Baltimore | MD | 21202 |
| K141706 | VISICU, INC. |
217 E. REDWOOD ST., STE. 1900 | BALTIMORE | MD | 21202 |
| K141167 | VITAL CONNECT INC. |
900 E. HAMILTON AVE., | CAMPBELL | CA | 95008 |
| K132447 | Vital Connect, Inc |
900 E. Hamilton Ave. Ste # 500 | Campbell | CA | 95008 |
| K152139 | VITAL CONNECT, INC. |
900 E. HAMILTON AVENUE, SUITE 500 | CAMPBELL | CA | 95008 |
| K163453 | VITAL CONNECT, INC. |
900 E. HAMILTON AVENUE | CAMPBELL | CA | 95008 |
| K193343 | VitalConnect, Inc. |
224 Airport Parkway, Suite 300 | San Jose | CA | 95110 |
| K183078 | VitalConnect, Inc. |
224 Airport Parkway, Suite 300 | San Jose | CA | 95110 |
| K192757 | VitalConnect, Inc. |
224 Airport Parkway, Suite 300 | San Jose | CA | 95110 |
| K190916 | VitalConnect, Inc. |
224 Airport Parkway, Suite 300 | San Jose | CA | 95110 |
| K170973 | VitalConnect, Inc. |
224 Airport Parkway, Suite 300 | San Jose | CA | 95110 |
| K191620 | Vitls Inc. |
TMC Innovation Institute, Suite X, 2450 Holcombe Blvd. | Houston | TX | 77021 |
| K191870 | VivaLNK, Inc. |
51 E. Campbell Ave. Suite 160 | Campbell | CA | 95008 |
| K222398 | Vivify Health, Inc. |
7201 Bishop Rd. | Plano | TX | 75024 |
| K111922 | VOCARE, INC |
5225 EXPLORATION DRIVE | INDIANAPOLIS | IN | 46241 |
| K110334 | WALDO HEALTH |
4505 SPICEWOOD SPRINGS ROAD, | AUSTIN | TX | 78759 |
| K120325 | WATERMARK MEDICAL |
12715 FALCON DRIVE | BROOKFIELD | WI | 53005 |
| K120470 | WATERMARK MEDICAL |
12715 FALCON DRIVE | BROOKFIELD | WI | 53005 |
| K122763 | ZEPHYR TECHNOLOGY CORPORATION |
1151 HOPE STREET | STAMFORD | CT | 06907 |
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