The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Peds Pulmonary Evaluation & Diagnostic System.
| Device ID | K864087 |
| 510k Number | K864087 |
| Device Name: | PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Contact | Myers, Jr. |
| Correspondent | Myers, Jr. 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 | 1986-10-21 |
| Decision Date | 1986-11-07 |