Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K760587 |
Device Name |
U-MID PREFILLED HUMIDIFIER (300CC) |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/03/1976 |
Decision Date | 10/15/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|