FDA 510(k) Application Details - K162571

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K162571
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Biotricity Inc. 75 International Blvd, Suite 300 Toronto M9W 6L9 CA Other 510(k) Applications for this Company
Contact	Tom Elias 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	09/15/2016
Decision Date	10/13/2016
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	Y
Expedited Review