|
Device |
humidifier, respiratory gas, (direct patient interface) |
Product Code | BTT |
Regulation Number |
868.5450
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
CARDINAL HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION 2200, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGER MEDICAL AG & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K143646 MR810 System, 900MR810 Adult Single Limb Circuit, ...
|
2. K191818 F&P Optiflow 3S Nasal Cannula (Small, Medium, Larg ...
|
3. K212031 F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
|
4. K222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface R ...
|
5. K223684 F&P 820 Humidification System
|
6. K231956 F&P Optiflow+ Duet Nasal Cannula
|
FISHER & PAYKEL HEALTHCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
1. K143646 MR810 System, 900MR810 Adult Single Limb Circuit, ...
|
2. K191818 F&P Optiflow 3S Nasal Cannula (Small, Medium, Larg ...
|
3. K212031 F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
|
4. K222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface R ...
|
5. K223684 F&P 820 Humidification System
|
6. K231956 F&P Optiflow+ Duet Nasal Cannula
|
FISHER & PAYKEL HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
FISHER &PAYKEL HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLEXICARE MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRUENDLER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRUNDLER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HAMILTON MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOMETA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDISIZE BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PACIFIC MEDICO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERMA PURE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SALTER LABS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SALTER LABS, ARVIN FACILITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOMNETICS INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL , INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TELESAIR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TNI MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VAPOTHERM INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VAPOTHERM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VENTLAB CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VINCENT HEALTHCARE PRODUCTS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYAIRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|