|
Device |
analyzer, gas, carbon-dioxide, gaseous-phase |
Product Code | CCK |
Regulation Number |
868.1400
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLUEPOINT MEDICAL GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CMI HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DRAEGERWERK AG & CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDURE INDUSTRIES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K213767 Endure ETCO2/02 Nasal Cannula
|
ENGINEERED MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE FINLAND OY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MASIMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIPINES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIHON KOHDEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORANTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIDION MEDICAL 1987 LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PNEUMA THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POM MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESPIRION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REVOLUTIONARY MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHMEDIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYLENOL MEDICAL INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMED MEDICAL SUPPLIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTURE THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYAIRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|