Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K941627 |
Device Name |
A&D UN-231 ULTRASONIC HANDY NEBULIZER |
Applicant |
A & D CORPORATE |
1555 MCCANDLESS DRIVE |
MILPITAS,
CA
95035
|
|
Applicant Contact |
JERRY P WANG |
Correspondent |
A & D CORPORATE |
1555 MCCANDLESS DRIVE |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
JERRY P WANG |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/04/1994 |
Decision Date | 12/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|