FDA 510(k) Applications for Medical Device:
Ventilator, Emergency, Powered (Resuscitator)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K080692 | AIRON CORPORATION |
129 W. HIBISCUS BLVD., SUITE S | MELBOURNE | FL | 32901 |
| K132021 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | Saint Louis | MO | 63110 |
| K070636 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST.LOUIS | MO | 63110 |
| K070120 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST.LOUIS | MO | 63110 |
| K083507 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K131098 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST LOUIS | MO | 63110 |
| K090356 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K080063 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K083385 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K072214 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K102542 | ATOM MEDICAL CORPORATION |
24301 WOODSTAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K131877 | AUTOMEDX INC. |
1420 Lakeside Parkway, Suite 102 | Flower Mound | TX | 75028 |
| K071221 | AUTOMEDX INC. |
12321 MIDDLEBROOK RD | GERMANTOWN | MD | 20874 |
| K132759 | DOLPHYS MEDICAL B.V. |
DE LISMORTEL 31 | EINDHOVEN | 5612AR | |
| K242769 | Draegerwerk AG & Co. KGaA |
Moislinger Allee 53-55 | Luebeck | 23542 | |
| K021520 | EMERGENCY MEDICAL TECHOLOGY |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K032386 | IMPACT INSTRUMENTATION, INC. |
27 FAIRFIELD PL. | WEST CALDWELL | NJ | 07006-0508 |
| K051476 | IMPACT INSTRUMENTATION, INC. |
27 FAIRFIELD PL. | WEST CALDWELL | NJ | 07006-0508 |
| K991785 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K140707 | INTERNATIONAL BIOMEDICAL |
8206 CROSS PARK DR. | AUSTIN | TX | 78754 |
| K182956 | International Biomedical |
8206 Cross Park Drive | Austin | TX | 78754 |
| K221634 | Magnamed Tecnologia Medica S/A |
801/831, Rua Santa Monica | Cotia | 06715-865 | |
| K142096 | MERCURY MEDICAL |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K093913 | MERCURY MEDICAL, INC. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K092085 | NEOFORCE GROUP, INC. |
35 COMMERCE DR. | IVYLAND | PA | 18974 |
| K051469 | O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. | MISSISSAUGA, ONTARIO | L5S 1C8 | |
| K051889 | O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. | MISSISSAUGA, ONTARIO | L5S 1C8 | |
| K093862 | O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. | MISSISSAUGA, ONTARIO | L5S 1C8 | |
| K081330 | O-TWO MEDICAL TECHNOLOGIES, INC. |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134-2958 |
| K141595 | O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. | MISSISSAUGA, ONTARIO | L5S 1C8 | |
| K983785 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST., UNIT 5 | ONTARIO L5S 1C8 | ||
| K983857 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST., UNIT 5 | ONTARIO L5S 1C8 | ||
| K991195 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST., UNIT 5 | ONTARIO L5S 1C8 | ||
| K983705 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST., UNIT 5 | ONTARIO L5S 1C8 | ||
| K983643 | O-TWO SYSTEMS INTL., INC. |
7575 KIMBEL ST. | MISSISSAUGA, ONTARIO | L5S 1C8 | |
| K070210 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K021841 | PNEU PAC, LTD. |
SMITHS MEDICAL | WAUKESHA | WI | 53186-1856 |
| K960515 | PNEU PAC, LTD. |
CRESCENT RD. | LUTON BEDS LU2 OAH | ||
| K020899 | PNEU PAC, LTD. |
SMITHS MEDICAL | WAUKESHA | WI | 53186-1856 |
| K030803 | PNEU PAC, LTD. |
SMITHS MEDICAL | WAUKESHA | WI | 53186-1856 |
| K040090 | PNEUPAC LTD. |
N7 W22025 JOHNSON ROAD | WAUKESHA | WI | 53186 |
| K123957 | SMITHS MEDICAL INTERNATIONAL LTD. |
BRAMINGHAM BUSINESS PARK | LUTON, BEDFORDSHIRE | LU3 4BU | |
| K043495 | SMITHS MEDICAL INTERNATIONAL LTD., LUTON |
N7 W22025 JOHNSON DRIVE | WAUKESHA | WI | 53186 |
| K071527 | SMITHS MEDICAL INTERNATIONAL, LTD. |
N7 W22025 JOHNSON DRIVE | WAUKESHA | WI | 53186 |
| K051322 | SMITHS MEDICAL INTERNATIONAL, LTD. |
N7 W22025 JOHNSON DRIVE | WAUKESHA | WI | |
| K982225 | SPIRACLE TECHNOLOGY |
16520 HARBOR BLVD., UNIT D | FOUNTAIN VALLEY | CA | 92708 |
| K093261 | THORNHILL RESEARCH INC |
70 PETER ST. 2ND FL. | TORONTO, ONTARIO | M5V 2G5 | |
| K140049 | THORNHILL RESEARCH INC |
210 DUNDAS STREET WEST | TORONTO | M5G2E8 | |
| K161420 | THORNHILL RESEARCH INC. |
210 DUNDAS STREET WEST, SUITE 200 | TORONTO | M5G 2E8 | |
| K112783 | VBM MEDIZINTECHNIK GMBH |
1, EINSTEINSTRASSE | BADEN-WURTTEMBERG | 72172 | |
| K173373 | Ventlab, LLC |
2710 Northridge Drive NW - Suite A | Grand Rapids | MI | 49544 |
| K001430 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST. | SACRAMENTO | CA | 95819 |
| K973975 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 | SACRAMENTO | CA | 95819 |
| K073261 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
21 GOLDEN LAND COURT | SACRAMENTO | CA | 95834 |
| K041473 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
1804 TRIBUTE RD., SUITE F | SACRAMENTO | CA | 95815 |
| K162968 | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
21 GOLDENLAND COURT, #100 | SACRAMENTO | CA | 95834 |
| K202219 | Vortran Medical Technology 1, Inc. |
21 Goldenland Court, Suite 100 | Sacramento | CA | 95834 |
| K193191 | Weinmann Emergency Medical Technology GmbH + Co. KG |
Frohb÷sestra▀e 12 | Hamburg | 22525 |
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