Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K962438 |
Device Name |
MISTY OX TURBOHEATER |
Applicant |
VITAL SIGNS, INC. |
1060 NORTH BATAVIA, UNIT H |
ORANGE,
CA
92867
|
|
Applicant Contact |
DOUGLAS R MONGEON |
Correspondent |
VITAL SIGNS, INC. |
1060 NORTH BATAVIA, UNIT H |
ORANGE,
CA
92867
|
|
Correspondent Contact |
DOUGLAS R MONGEON |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/24/1996 |
Decision Date | 01/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|