FDA 510(k) Application Details - K964187

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K964187
Device Name	Detector And Alarm, Arrhythmia
Applicant	FUKUDA DENSHI USA, INC. 55 NORTHERN BLVD., SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	10/21/1996
Decision Date	05/01/1997
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