The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Pulmonary Forced Flow System (puffs).
| Device ID | K883008 |
| 510k Number | K883008 |
| Device Name: | PULMONARY FORCED FLOW SYSTEM (PUFFS) |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| 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 | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-18 |
| Decision Date | 1988-09-29 |