FDA 510(k) Application Details - K233110

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K233110
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Bardy Diagnostics, Inc. 220 120th Avenue NE, Suite 100 Bellevue, WA 98005 US Other 510(k) Applications for this Company
Contact	Ben Hornsey 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	09/27/2023
Decision Date	11/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review