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 |