The following data is part of a premarket notification filed by Pneumedics, Inc. with the FDA for Spiroloop-pulmonary Exercise System.
| Device ID | K863087 |
| 510k Number | K863087 |
| Device Name: | SPIROLOOP-PULMONARY EXERCISE SYSTEM |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | PNEUMEDICS, INC. 25 VAN ZANT ST. East Norwalk, CT 06855 |
| Contact | Richard P Imbruce |
| Correspondent | Richard P Imbruce PNEUMEDICS, INC. 25 VAN ZANT ST. East Norwalk, CT 06855 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-10-27 |