FDA 510(k) Application Details - K163535

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K163535
Device Name	Recorder, Magnetic Tape, Medical
Applicant	DMS-SERVICE LLC 11845 W OLYMPIC BLVD STE 880W LOS ANGELES, CA 90064 US Other 510(k) Applications for this Company
Contact	LYNDA COLE 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	12/16/2016
Decision Date	02/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review