FDA 510(k) Application Details - K955045

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K955045
Device Name	Electrocardiograph
Applicant	INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. ORLANDO, FL 32826 US Other 510(k) Applications for this Company
Contact	FRANCIS X CASEY Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/1995
Decision Date	07/11/1996
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