FDA 510(k) Application Details - K964593

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K964593
Device Name	Detector And Alarm, Arrhythmia
Applicant	S & W MEDICO TEKNIK A/S HERSTEDVANG 8 ALBERTSLUND DK-2620 DK Other 510(k) Applications for this Company
Contact	CARSTEN W JENSON 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	11/15/1996
Decision Date	06/30/1997
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