Device Classification Name |
nebulizer, medicinal, non-ventilatory (atomizer)
|
510(k) Number |
K872315 |
Device Name |
MISTMASTER |
Applicant |
SONORA RESPIRATORY PRODUCTS, INC. |
1180-Z STAR ROUTE |
SONORA,
CA
95370
|
|
Applicant Contact |
EDWARD J SVOBODA |
Correspondent |
SONORA RESPIRATORY PRODUCTS, INC. |
1180-Z STAR ROUTE |
SONORA,
CA
95370
|
|
Correspondent Contact |
EDWARD J SVOBODA |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 06/17/1987 |
Decision Date | 09/11/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|