The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Pti-a, Pti-p, Pti-n Disposable Pneumotachs.
| Device ID | K921178 |
| 510k Number | K921178 |
| Device Name: | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS |
| Classification | Pneumotachometer |
| Applicant | MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Product Code | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-08-26 |