FDA 510(k) Applications for Medical Device:
Monitor, Breathing Frequency
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961972 | AEQUITRON MEDICAL, INC. |
14800 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K981728 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K051779 | ANDROMED, INC. |
4610 CHEMIN DU BOIS-FRANC | SAINT LAURENT, QUEBEC | H4S 1A7 | |
| K223246 | Baxter Healthcare Corproration |
1069 State Route 46 East | Batesville | IN | 47006 |
| K103631 | BIANCAMED LIMITED |
NOVAUCD, BELFIELD INNOVATION P | BELFIELD, DUBLIN | 4 | |
| K984431 | BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE | KANATA | K2K 2H7 | |
| K981445 | BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE | KANATA | K2K 2H7 | |
| K982216 | BRAEBON MEDICAL CORP. |
63 ACKLAM TERRACE | KANATA | K2K 2H7 | |
| K001743 | BRAEBON MEDICAL CORP. |
120 WALGREEN DR (RR#3) | CARP, ONTARIO | K0A 1L0 | |
| K200445 | Circadia Technologies Ltd. |
6 Delmey Close | Croydon | CR0 5QD | |
| K111933 | COVIDIEN |
6135 GUNBARREL AVE. | BOULDER | CO | 80301 |
| K040605 | DYMEDIX, INC. |
800 LEVANGER LN. | STOUGHTON | WI | 53589 |
| K001030 | DYMEDIX, INC. |
800 LEVANGER LN. | STOUGHTON | WI | 53589 |
| K133661 | EARLYSENSE LTD. |
12 TZVI STREET | RAMAT GAN | 52504 | |
| K131379 | EARLYSENSE LTD. |
12 TZVI ST | RAMAT-GAN | 52504 | |
| K120465 | EARLYSENSE LTD. |
12 TZVI STREET | RAMAT GAN | 52504 | |
| K171836 | EarlySense Ltd. |
7 Derech Zeev Jabotinsky | Ramat Gan | 5252007 | |
| K070375 | EARLYSENSE LTD. |
7, JABOTINSKY ST. | RAMAT GAN | 52520 | |
| K152911 | EarlySense Ltd. |
12 Tzvi Street | Ramat Gan | 5250429 | |
| K082465 | EARLYSENSE LTD. |
12 TZVI STREET | RAMAT GAN | 52504 | |
| K092062 | EARLYSENSE LTD. |
TZVI 12 | RAMAT-GAN | 52504 | |
| K953363 | EDENTEC CORP. |
10252 VALLEY VIEW RD. | EDEN PRAIRIE | MN | 55344 |
| K243966 | FaceHeart Corp. |
PO Box 309, Ugland House | Grand Cayman | KY1-1104 | |
| K962781 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH | WALLINGFORD | CT | 06492 |
| K983449 | GEREONICS, INC. |
4650-143 DULIN RD. | FALLBROOK | CA | 92028 |
| K062883 | GEREONICS, INC. |
244 LA BARRANCA DRIVE | SOLANA BEACH | CA | 92075 |
| K991411 | GEREONICS, INC. |
4650-143 DULIN RD. | FALLBROOK | CA | 92028 |
| K242798 | Heroic Faith International Ltd. |
18F., No. 460, Sec. 4, Xinyi Rd., Xinyi Dist. | Taipei City | 110 | |
| K180079 | Hill-Rom Inc. |
1069 State Route 46 East | Batesville | IN | 47006 |
| K202018 | Hill-Rom, Inc. |
1069 State Route 46 East | Batesville | IN | 47006 |
| K100773 | KAI MEDICAL, INC. |
3465 WAIALAE AVE SUITE 370 | HONOLULU | HI | 96816 |
| K090273 | KAI SENSORS, INC |
3465 WAIALAE AVENUE | HONOLULU | HI | 96816 |
| K190734 | Linshom Management LLC |
2922 Excelsior Springs Court | Ellicott City | MD | 21042 |
| K240271 | Linshom Medical Inc. |
2922 Excelsior Springs Court | Ellicott City | MD | 21042 |
| K233953 | Makani Science, Inc. |
5270 California Avenue, Suite 300 | Irvine | CA | 92617 |
| K173976 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K130570 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE | VENTURA | CA | 93003 |
| K003704 | OPTOVENT AB |
1350 15TH STREET, SUITE 4H | FORT LEE | NJ | 07024 |
| K981725 | OPTOVENT, INC. |
1350 FIFTEENTH ST. | FORT LEE | NJ | 07024 |
| K242001 | Philips Medical Systems Nederland B.V. |
High Tech Campus 34 | Eindhoven | 5656 AE | |
| K122223 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BOEBLINGEN | 71034 | |
| K132320 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K220111 | PMD Solutions |
Bishopstown House Model Farm Rd | Cork | T12 T922 | |
| K151940 | PneumaCare LIMITED |
ST. JOHNS INNOVATION CENTRE, COWLEY ROAD | CAMBRIDGE | CB4 0WS | |
| K960851 | PRO-TECH SERVICES, INC. |
12826 N.W. 178TH ST., SUITE A | WOODINVILLE | WA | 98072 |
| K223681 | Respiree PTE Ltd. |
115 East Coast Rd | Singapore | 428804 | |
| K982550 | RESPIRONICS, INC. |
1501 ARDMORE BLVD. | PITTSBURGH | PA | 15221-4401 |
| K243183 | RTM Vital Signs, LLC |
8 Richards Way | Ambler | PA | 19002-2532 |
| K092685 | SALTER LABS |
100 W. SYCAMORE RD. | ARVIN | CA | 93203 |
| K080922 | SALTER LABS, DIVISION OF REGULATORY AFFAIRS |
100 WEST SYCAMORE RD. | ARVIN | CA | 93203 |
| K190775 | Shenzhen Fiber Medical Technology Co. Ltd. |
Room 501, Sun Mate Science and Technology Mansion | Shenzhen | 518057 | |
| K211387 | Sound Life Sciences, Inc. |
Startup Hall, Box 354625, 1100 NE Campus Parkway, Suite 200 | Seattle | WA | 98195-4625 |
| K221555 | Turtle Shell Technologies Private Limited |
#40, City Centre, Ground and Mezzanine Floor, | Bengaluru | 560038 |
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