FDA 510(k) Application Details - K950537

Device Classification Name	Phonocardiograph   More FDA Info for this Device
510(K) Number	K950537
Device Name	Phonocardiograph
Applicant	CARDIOPHONICS, INC. 1 KEN PLACE PORT JEFFERSON STATION, NY 11776 US Other 510(k) Applications for this Company
Contact	MICHAEL F ZANAKIS Other 510(k) Applications for this Contact
Regulation Number	870.2390   More FDA Info for this Regulation Number
Classification Product Code	DQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/1995
Decision Date	03/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review