FDA 510(k) Application Details - K960884

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K960884
Device Name	Detector And Alarm, Arrhythmia
Applicant	LIFE SENSING INSTRUMENT COMPANY, INC. 329 WEST LINCOLN ST. TULLAHOMA, TN 37388 US Other 510(k) Applications for this Company
Contact	B Q CUTSHAW 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	03/04/1996
Decision Date	09/12/1997
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