| Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
| 510(k) Number |
K881122 |
| Device Name |
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. |
| Applicant |
| Medical Associated Services, Inc. |
| P.O. Box 530 |
|
Hatfield,
PA
19440
|
|
| Applicant Contact |
MICHAEL A SIMPSON |
| Correspondent |
| Medical Associated Services, Inc. |
| P.O. Box 530 |
|
Hatfield,
PA
19440
|
|
| Correspondent Contact |
MICHAEL A SIMPSON |
| Regulation Number | 868.1890 |
| Classification Product Code |
|
| Date Received | 03/16/1988 |
| Decision Date | 06/10/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|