The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Updated Manual For Peds - Pulmonary Eval. & Diag..
| Device ID | K881122 |
| 510k Number | K881122 |
| Device Name: | UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Contact | Michael A Simpson |
| Correspondent | Michael A Simpson MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-16 |
| Decision Date | 1988-06-10 |