The following data is part of a premarket notification filed by Cardiophonics, Inc. with the FDA for Cardiophonics Incorporated Dps 2000 Phonocardiograph.
| Device ID | K950537 |
| 510k Number | K950537 |
| Device Name: | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH |
| Classification | Phonocardiograph |
| Applicant | CARDIOPHONICS, INC. 1 KEN PLACE Port Jefferson Station, NY 11776 |
| Contact | Michael F Zanakis |
| Correspondent | Michael F Zanakis CARDIOPHONICS, INC. 1 KEN PLACE Port Jefferson Station, NY 11776 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-07 |
| Decision Date | 1996-03-01 |