Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K070411 |
Device Name |
AMSURE NEBULIZER |
Applicant |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. |
POMONA,
CA
91767
|
|
Applicant Contact |
CHING C SEAH |
Correspondent |
AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DR. |
POMONA,
CA
91767
|
|
Correspondent Contact |
CHING C SEAH |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/12/2007 |
Decision Date | 10/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|