FDA 510(k) Application Details - K112921

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K112921
Device Name	Detector And Alarm, Arrhythmia
Applicant	MEDICAL.GORITHMICS S.A. 245 WEST 107TH ST. SUITE 11A NEW YORK, NY 10025 US Other 510(k) Applications for this Company
Contact	MARTIN JASINSKI 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	10/03/2011
Decision Date	05/16/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review