|
Device |
nebulizer (direct patient interface) |
Product Code | CAF |
Regulation Number |
868.5630
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACTIVAERO AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADHERIUM (NZ) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
AEROGEN IRELAND, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEROGEN LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEROGEN LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AEROGEN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIREHEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARMSTRONG MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLANTEAN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BESMED HEALTH BUSINESS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BREATHESUITE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COGNITA LABS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVEXITY SCIENTIFIC LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIAGNOSTIC DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIGIO2 INTERNATIONAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXCELLENTCARE MEDICAL (HUIZHOU) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FEELLIFE HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HCMED INNOVATIONS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEADSTAR MEDICAL PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRUMENTATION INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K-JUMP HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KOO(SHANGHAI)INDUSTRIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MANKIND PHARMA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTIRES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERITS HEALTH PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROBASE TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROVAPER DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MONAGHAN MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEPHRON PHARMACEUTICALS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEXUS6, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OCHSNER CLINIC FOUNDATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ODYSSEY MEDICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMRON HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARI RESPIRATORY EQUIPMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
PEGASUS RESEARCH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHARMACARIBE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUALITY LIFE TECHNOLOGIES CO;LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RECIPROCAL LABS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
RECIPROCAL LABS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
RESPIRONICS NEW JERSEY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROLLINS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HOMED MEDICAL DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HOMED MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IVANKACA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHMEDIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEVE ISLAVA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TELEFLEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
THAYER MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAYER MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THE RITEDOSE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRUDELL MEDICAL INT'L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRUDELL MEDICAL INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TRUDELL MEDICAL INTL. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VAPOTHERM INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VECTURA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTLAB CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|