FDA 510(k) Applications for Medical Device:
Stethoscope, Electronic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K003723 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55133-3275 |
| K041934 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K083903 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K051790 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55144-1000 |
| K050159 | 3M COMPANY |
3M CENTER, BLDG. 275-5W-06 | ST. PAUL | MN | 55133-3275 |
| K103499 | ACTIVE SIGNAL TECHNOLOGIES, INC. |
11874 SOUTH EVELYN CIR. | HOUSTON | TX | 77071 |
| K993623 | ALLEN MEDICAL INSTRUMENTS CORP. |
505 SUPERIOR AVE. | NEWPORT BEACH | CA | 92663 |
| K012304 | AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. | HAUPPAUGE | NY | 11788 |
| K060321 | AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. | HAUPPAUGE | NY | 11788 |
| K162589 | AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. | HAUPPAUGE | NY | 11788 |
| K963678 | AMERICAN TELECARE, INC. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K010729 | ANDROMED, INC. |
4610 CHEMIN DU BOIS-FRANC | SAINT LAURENT, QUEBEC | H4S 1A7 | |
| K021389 | ANDROMED, INC. |
4610 CHEMIN DU BOIS-FRANC | SAINT LAURENT, QUEBEC | H4S 1A7 | |
| K022298 | ANDROMED, INC. |
4610 CHEMIN DU BOIS-FRANC | SAINT LAURENT, QUEBEC | H4S 1A7 | |
| K001306 | ANDROMED, INC. |
2310 BOUL ALFRED-NOBEL | ST.LAURENT, QUEBEC | H4S 2A4 | |
| K170928 | AUM Cardiovascular, Inc. |
1405 Heritage Dr, Suite 100 | Northfield | MN | 55057 |
| K230823 | AusculThing Oy |
Ruusutorpanpuisto 4 A 15 | Espoo | 02600 | |
| K183710 | Avicena LLC |
2400 Lincoln Ave, Suite 213 | Altadena | CA | 91001 |
| K991756 | BIO-RESEARCH ASSOCIATES, INC. |
4113 NORTH PORT WASHINGTON RD. | MILWAUKEE | WI | 53212 |
| K990809 | CADITEC AG |
ONE MEDICAL PLACE | MUNDELEIN | IL | 60060 |
| K181882 | Chip Ideas Electronics S.L |
Calle Clariano 8, Entresuelo B | Valencia | 46021 | |
| K201742 | Chip Ideas Electronics S.L |
Calle Alfareria 3 B | Burjasot | 46100 | |
| K212013 | Chip Ideas Electronics S.L. |
C/ Alfareria 3 B | Burjasot | 46100 | |
| K203007 | Chip Ideas Electronics S.L. |
Calle Alfareria 3 B | Burjasot | 46100 | |
| K211779 | Chip Ideas Electronics S.L. |
Calle Alfareria 3 B | Burjasot | 46100 | |
| K220766 | CSD Labs GmbH |
Nikolaiplatz 4 | Graz | 8020 | |
| K181988 | CSD Labs GmbH |
Niklaiplatz 4 | Graz | 8020 | |
| K003485 | CYBERCARE TECHNOLOGIES, INC. |
7840 ROSWELL RD., BLDG. 300 | ATLANTA | GA | 30350-4889 |
| K002984 | CYBERCARE TECHNOLOGIES, INC. |
7840 ROSWELL RD., BLDG. 300 | ATLANTA | GA | 30350-4889 |
| K961301 | DELPHI CONSULTING GROUP |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K961937 | DELPHI CONSULTING GROUP |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K121617 | DIACOUSTIC MEDICAL (PTY) |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K110704 | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. |
1468 Harwell Avenue | Crofton | MD | 21114 |
| K131044 | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. |
1468 Harwell Avenue | Crofton | MD | 21114 |
| K991714 | DOCTOR'S RESEARCH GROUP, INC. |
143 WOLCOTT RD. | WOLCOTT | CT | 06716 |
| K002047 | DOCTOR'S RESEARCH GROUP, INC. |
143 WOLCOTT RD. | WOLCOTT | CT | 06716 |
| K062364 | DONGJIN MEDICAL CO., LTD |
#1022 SICOX TOWER, 513-14 | SUNGNAM-SI, KYUNGGI-DO | 462-806 | |
| K011898 | E-MED INNOVATIONS, INC. |
2200 ROSS AVENUE, SUITE 2200 | DALLAS | TX | 75201-6776 |
| K230111 | Eko Devices, Inc. |
1212 Broadway, Suite 100 | Oakland | CA | 94612 |
| K200776 | Eko Devices, Inc. |
1212 Broadway, Suite 100 | Oakland | CA | 94612 |
| K151319 | Eko Devices, Inc. |
2600 10th St, Suite 260 | Berkeley | CA | 94710 |
| K170874 | Eko Devices, Inc. |
2600 10th St, Suite 260 | Berkeley | CA | 94710 |
| K213794 | Eko Devices, Inc. |
1212 Broadway, Suite 100 | Oakland | CA | 94612 |
| K211068 | Entac Medical Inc. |
680 Oakleaf Office Lane, Suite 201 | Memphis | TN | 38117 |
| K230769 | Entac Medical Inc. |
680 Oalkleaf Office Lance, Suite 201 | Memphis | TN | 38117 |
| K001788 | ERECORDS ENTERPRISES |
801 YORK MILLS ROAD | TORONTO | ||
| K021087 | ERECORDS LIMITED |
801 YORK MILLS ROAD | TORONTO | M3B 1X7 | |
| K150782 | GI Logic Inc |
909 East Green Street | Pasadena | CA | 91106 |
| K961857 | GRAHAM-FIELD, INC. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K031446 | GS TECHNOLOGY CO., LTD. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K210736 | GV Concepts |
3240 S White Rd #286 | San Jose | CA | 95148 |
| K100531 | HD MEDICAL SERVICES (INDIA) PVT.LTD |
11143 TWINLEAF WAY | SAN DIEGO | CA | 92131 |
| K201299 | HD Medical, Inc. |
3561 Homestead Road #146 | Santa Clara | CA | 95051 |
| K050169 | HEALTH & LIFE CO., LTD. |
3892 SOUTH AMERICA WEST TRAIL | FLAGGSTAFF | AZ | 86001 |
| K212906 | Heartbuds LLC |
711 London Road | Winter Park | FL | 32792 |
| K191667 | Hefei Mintti Medical Technology Co., Ltd. China |
C309, National University Science Park, 602 Huangshan Road, | Hefei | 230088 | |
| K221805 | Heroic Faith International Ltd. |
18F., No. 460, Section 4, Xinyi Road, Xinyi District | Taipei City | 110 | |
| K220099 | HomeDiagnostic LLC |
3160 De La Cruz Blvd | Santa Clara | CA | 95054 |
| K160023 | IMEDIPLUS INC. |
2F, 12, SHENGYI RD.SEC.2 | CHUBEI CITY | 30261 | |
| K173663 | IMEDIPLUS INC. |
2F, 12, Shengyi Rd.Sec.2 | Chupei City | 30261 | |
| K182196 | Imediplus, Inc. |
2F, 12, ShengYi Rd. Sec.2 | Chupei City | 30261 | |
| K103516 | INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE | BEAVERTON | OR | 97008-7196 |
| K051450 | INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. | PORTLAND | OR | 97223 |
| K070550 | KORATEK COMPANY, LTD. |
1733 CANTON LANE | MARIETTA | GA | 30062 |
| K193631 | M3DICINE Pty Ltd. |
Level 1, 88 Brandl Street | Eight Mile Plains | 4113 | |
| K172296 | M3dicine Pty. Ltd. |
1389 Beenleigh Road | Brisbane | 4112 | |
| K223166 | Medaica Inc. |
170 S. Green Valley Pkwy Ste 300 | Henderson | NV | 89012 |
| K013725 | MEDITRON AS |
103 NOLEN LN. | CHAPEL HILL | NC | 27516 |
| K991367 | MEDITRON AS |
11902 SIMPSON RD. | CLARKSVILLE | MD | 21029 |
| K961848 | MINNESOTA MINING AND MFG. CO. |
3M CENTER, BUILDING 275-3E-08 | ST. PAUL | MN | 55133-3275 |
| K202483 | MyHomeDoc Ltd. |
13 Zarchin St. | Ra'anana | 4366241 | |
| K082528 | NOBLE ANESTHESIA-AIR, INC. |
277 ZANE COURT | ELIZABETH | CO | 80107 |
| K223785 | Nonagon Ltd. |
1 HaEshel St. | Caesarea | 3079830 | |
| K123148 | PARACE LLC |
PO BOX 171 | YORKTOWN HEIGHTS | NY | 10598 |
| K062481 | PISHON HIGH TECH CO., LTD. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K082771 | PROTRON TECHNOLOGIES, LLC |
141 OAKDENE AVE. | LEONIA | NJ | 07605 |
| K131287 | RIJUVEN CORP |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K034046 | RNK PRODUCTS |
12700 DIAMOND DRIVE | BURNSVILLE | MN | 55337 |
| K132560 | RNK PRODUCTS, INC. |
8247 Devereux Dr Ste 101 | Melbourne | FL | 32940 |
| K102893 | RNK PRODUCTS, INC. |
4195 US HWY 1 | ROCKLEDGE | FL | 32955 |
| K132405 | RNK PRODUCTS, INC. |
8247 Devereux Dr Ste 101 | Melbourne | FL | 32940 |
| K072026 | RNK PRODUCTS, INC. |
12700 DIAMOND DRIVE | BURNSVILLE | MN | 55337 |
| K081032 | RNK PRODUCTS, INC. |
12700 DIAMOND DRIVE | BURNSVILLE | MN | 55337 |
| K212709 | Sanolla Ltd. |
19 Ha'Mesilla Street | Nesher | 3688519 | |
| K220470 | Shanghai Hulu Devices Co., Ltd |
No. 509 Caobao Road, Room 101-2 Building 9, Xuhui District | Shanghai | 200233 | |
| K121144 | SHARP CORPORATION |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K230613 | Smartsound Corporation |
171, Yangjaecheon-ro, Gangnam-gu | Seoul | 06302 | |
| K200862 | Sonavi Labs, Inc. |
1100 Wicomico St., Suite 600 | Baltimore | MD | 21230 |
| K023759 | SONOMEDICA |
8230 LEESBURG PIKE | VIENNA | VA | 22182 |
| K220466 | Sound Land Corp. |
No.32, Keji 1st Rd., Guishan Dist. | Taoyuan | 33383 | |
| K222871 | Sparrow Acoustics Inc. |
2416 Natura Dr | Lucasville | B4B0X3 | |
| K173448 | StethoCloud Pty.Ltd (CliniCloud) |
Level 5, 141 Flinders Lane | Melbourne VIC | 3000 | |
| K052283 | STETHOGRAPHICS, INC. |
1153 CENTRE STREET | BOSTON | MA | 02130 |
| K091972 | STETHOSCOPE TECHNOLOGIES, INC |
38 MILLER AVE | MILL VALLEY | CA | 94941 |
| K220196 | StratoScientific |
19125 North Creek Pkwy #120 | Bothell | WA | 98011 |
| K160016 | STRATOSCIENTIFIC, INC. |
1574 NORTHWEST 190TH STREET | SHORELINE | WA | 98177 |
| K050097 | TECHTRADE LLC |
11900 GAINSBOROUGH ROAD | POTOMAC | MD | 20854-3305 |
| K963621 | THERATECHNOLOGIES, INC. |
7701, 17TH AVENUE | MONTREAL, QUEBEC | H2A 2S5 | |
| K032230 | THINKLABS INC. |
30 NORTHPORT ROAD | SOUND BEACH | NY | 11789 |
| K963418 | TRANSMEDICA, INC. |
2112B GALLOWS RD. | VIENNA | VA | 22182 |
| K023637 | TYTAN MEDICAL CORP. |
3892 SOUTH AMERICA WEST TRAIL | FLAGSTAFF | AZ | 86001 |
| K160401 | Tyto Care Ltd. |
Haomanut 12 | Netanya | 4205445 | |
| K181612 | Tyto Care Ltd. |
12 Haomanut Street | Netanya | 4250445 | |
| K042128 | ZARGIS MEDICAL CORP. |
755 COLLEGE RD. EAST | PRINCETON | NJ | 08540 |
| K090493 | ZARGIS MEDICAL CORP. |
2 RESEARCH WAY, 1ST FLOOR | PRINCETON | NJ | 08540 |
| K031517 | ZARGIS MEDICAL CORP. |
755 COLLEGE RD. EAST | PRINCETON | NJ | 08540 |
| K060197 | ZARGIS MEDICAL CORP. |
2 RESEARCH WAY | PRINCETON | NJ | 08540 |
| K083309 | ZARGIS MEDICAL CORP. |
2 RESEARCH WAY, 1ST FLOOR | PRINCETON | NJ | 08540 |
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