FDA 510(k) Application Details - K171936

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K171936
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Peerbridge Health INc. 1440 Broadway, 23rd Floor New York, NY 10018 US Other 510(k) Applications for this Company
Contact	Arthur A. Bertolero 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	06/28/2017
Decision Date	09/27/2017
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	Y
Expedited Review