FDA 510(k) Application Details - K153477

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K153477
Device Name	Detector And Alarm, Arrhythmia
Applicant	VITASYSTEMS GMBH MARKIRCHER STR. 22 Mannheim 68229 DE Other 510(k) Applications for this Company
Contact	Michael Rothhaar 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	12/02/2015
Decision Date	05/25/2016
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