FDA 510(k) Application Details - K143067

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K143067
Device Name	Recorder, Magnetic Tape, Medical
Applicant	BARDY DIAGNOSTICS, INC. 17141 VASHON HIGHWAY, SW. VASHON ISLAND, WA 98070 US Other 510(k) Applications for this Company
Contact	JON P. HUNT 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	10/24/2014
Decision Date	12/22/2014
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