FDA 510(k) Applications for Medical Device:
Ventilator, Emergency, Manual (Resuscitator)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K112852 | A PLUS MEDICAL |
5431 AVENIDA ENCINAS | CARLSBAD | CA | 92008 |
| K973106 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K014071 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K073171 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST. LOUIS | MO | 63110 |
| K062080 | ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. | ST.LOUIS | MO | 63110 |
| K053142 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K053140 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K102824 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K152931 | AMBU A/S |
BALTORPBAKKEN 13 | BALLERUP | DK-2750 | |
| K993278 | AMBU, INC. |
611 NORTH HAMMONDS FERRY RD. | LINTHICUM | MD | 21090-1356 |
| K042843 | AMBU, INC. |
611 NORTH HAMMONDS FERRY ROAD | LINTHICUM | MD | 21090-1356 |
| K042682 | AMBU, INC. |
611 NORTH HAMMONDS FERRY ROAD | LINTHICUM | MD | 21090-1356 |
| K964584 | AMBU, INC. |
611 N. HAMMONDS FERRY RD. | LINTHICUM | MD | 21090-1356 |
| K221841 | ARCHEON |
2 Chemin des Aiguillettes | Besanτon | 25000 | |
| K073410 | ARTIVENT CORPORATION |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K031434 | BAWMED UK |
6 GREAT HOUSE MEADOWS | UNITED KINGDOM | CF61 ISU. | |
| K021390 | CHEEN HOUNG ENT. CO. LTD. |
23 SAN DREEN ST., ALLEY 11, | TAIPEI (SHULIN) | 23805 | |
| K003927 | CHEEN HOUNG ENT. CO. LTD. |
23 ALLEY 11 LANE 65 SAN DREEN | TAIPEI (SHULIN) | 23805 | |
| K243861 | Compact Medical, Inc. |
525 South Meridian St. | Indianapolis | IN | 46259 |
| K051177 | DAVID MEDICAL PRODUCTS CO.,LTD |
88 FUDA RD. LUDU | TAICANG,SUZHOU,JIANGSU | 215412 | |
| K972139 | DAVIS & GECK, INC. |
444 MC DONNELL BLVD. | HAZELWOOD | MO | 63042 |
| K991953 | ENGINEERED MEDICAL SYSTEMS |
2055 EXECUTIVE DR. | INDIANAPOLIS | IN | 46241 |
| K991955 | ENGINEERED MEDICAL SYSTEMS |
2055 EXECUTIVE DR. | INDIANAPOLIS | IN | 46241 |
| K042556 | ENTER MEDICAL CORPORATION |
NO.16-1, LANE 564 | GUI SHAN XIANG,TAO YUAN HSIEN | 333 | |
| K181583 | Flexicare Medical Limited |
Cynon Valley Business Park | Mountain Ash | cf45 4ER | |
| K170663 | Foremount Enterprise Co., Ltd. |
No. 17, Alley 15, Lane 5, Shenan St., Shengang Dist., | Taichung City | 42944 | |
| K082092 | GALEMED CORP. |
54431 AVENIDA ENCINAS | CARLSBAD | CA | 90228-4411 |
| K955507 | GRAYCO, INC. |
1212 7TH ST. | CLARKSTON | WA | 99403 |
| K002846 | HEADSTAR MEDICAL PRODUCTS CO., LTD |
NO 23, LANE 431, HWA CHEN RD | TAIPEI HSIEN | ROC 242 | |
| K094003 | HERSILL, S.L. |
PUERTO DE NAVACERRADA, 3 | MOSTOLES ( MADRID) | 28935 | |
| K053466 | HSINER CO., LTD. |
29201 VIA NORTE | TEMECULA | CA | 92591 |
| K964719 | HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. | TEMECULA | CA | 92589-9020 |
| K012271 | IMPOEX INTERNATIONAL, LTD. |
500 EAGLE WAY #18 | LITTLE RIVER | SC | 29566 |
| K970959 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K981308 | INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K981307 | INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K132172 | LAERDAL MEDICAL A/S |
TANKE SVILANDSGT. 30 | STAVANGER | N-4000 | |
| K961329 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K961330 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K961331 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K961332 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K961369 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K953546 | MEDICAL MARKETING CONCEPTS |
20 BREEDEN COURT | HARDY | VA | 24101 |
| K982215 | MEDICAL MARKETING CONCEPTS |
P.O. BOX 4341 | CROFTON | MD | 21114-4341 |
| K961868 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K961882 | MEDICAL MARKETING CONCEPTS |
2310 YORK RD. | ROANOKE | VA | 24015 |
| K954866 | MERCURY MEDICAL |
11300 49TH ST. NORTH | CLEARWATER | FL | 33762-4800 |
| K970756 | MERCURY MEDICAL |
11300-A 49TH ST. NORTH | CLEARWATER | FL | 34622-4800 |
| K031395 | MERLIN MEDICAL LIMITED |
THE WHITBREAD CENTRE,RHYMNEY, | UNITED KINGDOM | NP22 5BF | |
| K093081 | MICROBVM SYSTEMS LTD |
POB 6718 | EFRAT | 90435 | |
| K973419 | NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. | PLEASANTON | CA | 94588-2719 |
| K960468 | NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. | PLEASANTON | CA | 94588-2719 |
| K023494 | NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. | PLEASANTON | CA | 94588-2719 |
| K072021 | NEOFORCE GROUP, INC. |
35 COMMERCE DR. | IVYLAND | PA | 18974 |
| K102649 | NEOFORCE GROUP, INC. |
35 COMMERCE DR. | IVYLAND | PA | 18974 |
| K021328 | O-TWO SYSTEMS INTERNATIONAL INC. |
7575 KIMBEL ST. | MISSISSAUGA,ONTARIO | L5S 1C8 | |
| K021446 | OEMEDIC INTERNATIONAL, INC. |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K021442 | OEMEDIC INTERNATIONAL, INC. |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K070247 | OHMEDA MEDICAL |
8880 GORMAN RD. | LAUREL | MD | 20723 |
| K971243 | OHMEDA MEDICAL |
9065 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K963848 | OWENS-BRIGAM MEDICAL CO. |
65 HANES RD. | NEWLAND | NC | 28657 |
| K980066 | PLASCO, INC. |
4080 MORRISON DR. | GURNEE | IL | 60031 |
| K021716 | POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. |
UNIT B,1-5 F,WAREHOUSE & PROC. | XIAMEN | ||
| K023793 | PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K014115 | PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K970991 | PROMEDIC, INC. |
6329 WEST WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K993194 | RUSCH, INC. |
2450 MEADOWBROOK PKWY. | DULUTH | GA | 30096 |
| K212905 | Safe BVM Corporation |
1120 Weidman Road | Chesterfield | MO | 63017 |
| K974141 | SCHIFF & CO. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K972283 | SIMS |
5100 TICE ST. | FT. MYERS | FL | 33905 |
| K991861 | SIMS PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K992057 | SIMS PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K032596 | STURDY INDUSTRIAL CO., LTD |
6833 SAINT LAWRENCE STREET | PLANO | TX | 75024 |
| K030864 | VEDI CORP. |
6833 SAINT LAWRENCE ST. | PLANO | TX | 75024 |
| K012842 | VENTLAB CORP. |
2934 HWY. 601 NORTH | MOCKSVILLE | NC | 27028 |
| K210288 | Xiamen Compower Medical Tech. Co., Ltd. |
Unit 301, No.16, Xianghong Road, | Xiamen | 361101 |
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