codes
Device Classification Name |
compressor, air, portable |
|||
---|---|---|---|---|
510(k) Number | K002468 | |||
Device Name | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | |||
Original Applicant |
|
|||
Original Contact | susan d goldstein-falk | |||
Regulation Number | 868.6250 | |||
Classification Product Code |
|
|||
Date Received | 08/11/2000 | |||
Decision Date | 03/02/2001 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Anesthesiology |
|||
510k Review Panel |
Anesthesiology |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |