FDA 510(k) Application Details - K171410

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K171410
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Braemar Manufacturing, LLC 3890 Murphy Canyon Road, Suite 100 San Diego, CA 92123 US Other 510(k) Applications for this Company
Contact	Kent Sayler Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2017
Decision Date	01/04/2018
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