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 |