FDA 510(k) Application Details - K191471

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K191471
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Bardy Diagnostics, Inc 316 Occidental Avenue South, Suite B310 Seattle, WA 98104 US Other 510(k) Applications for this Company
Contact	Brit Baird 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	06/03/2019
Decision Date	08/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review