FDA 510(k) Application Details - K974697

Device Classification Name	Cardiograph, Apex (Vibrocardiograph)   More FDA Info for this Device
510(K) Number	K974697
Device Name	Cardiograph, Apex (Vibrocardiograph)
Applicant	BCI INTL., INC. W238 N1650 ROCKWOOD DR. WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	DONALD J ALEXANDER Other 510(k) Applications for this Contact
Regulation Number	870.2310   More FDA Info for this Regulation Number
Classification Product Code	DQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/1997
Decision Date	03/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review