FDA 510(k) Application Details - K210036

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K210036
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	Jocelyn Kersten 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	01/06/2021
Decision Date	02/05/2021
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