The following data is part of a premarket notification filed by Pneumedics, Inc. with the FDA for Models Pb950 And Pb960 Dataloop And Spiroloop.
| Device ID | K894667 |
| 510k Number | K894667 |
| Device Name: | MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford, CT 06460 |
| Contact | P Imbruce |
| Correspondent | P Imbruce PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford, CT 06460 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-10-19 |