Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K964994 |
Device Name |
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR |
Applicant |
CONTEMPORARY PRODUCTS, INC. |
530 RIVERSIDE INDUSTRIAL PWKY. |
PORTLAND,
ME
04103 -1066
|
|
Applicant Contact |
BARRY A SCHWARTZ |
Correspondent |
CONTEMPORARY PRODUCTS, INC. |
530 RIVERSIDE INDUSTRIAL PWKY. |
PORTLAND,
ME
04103 -1066
|
|
Correspondent Contact |
BARRY A SCHWARTZ |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/16/1996 |
Decision Date | 02/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|