Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K952326 |
Device Name |
PULMOMIST |
Applicant |
GLOBAL MEDICAL ENT., INC. |
1590 WEST 35TH PL. |
HIALEAH,
FL
33012
|
|
Applicant Contact |
SALVADOR CASTANER |
Correspondent |
GLOBAL MEDICAL ENT., INC. |
1590 WEST 35TH PL. |
HIALEAH,
FL
33012
|
|
Correspondent Contact |
SALVADOR CASTANER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/18/1995 |
Decision Date | 02/27/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|