510(k) K950537

CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH by Cardiophonics, Inc. — Product Code DQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1996
Date Received
February 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phonocardiograph
Device Class
Class I
Regulation Number
870.2390
Review Panel
CV
Submission Type