FDA 510(k) Application Details - K980045

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K980045
Device Name	Detector And Alarm, Arrhythmia
Applicant	INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. ORLANDO, FL 32826 US Other 510(k) Applications for this Company
Contact	FRANCIX X CASEY Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1998
Decision Date	11/16/1998
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