Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K883008 |
Device Name |
PULMONARY FORCED FLOW SYSTEM (PUFFS) |
Applicant |
MEDICAL ASSOCIATED SERVICES, INC. |
P.O. BOX 530 |
HATFIELD,
PA
19440
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
MEDICAL ASSOCIATED SERVICES, INC. |
P.O. BOX 530 |
HATFIELD,
PA
19440
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 07/18/1988 |
Decision Date | 09/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|