FDA 510(k) Application Details - K160260

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K160260
Device Name	Electrode, Pacemaker, Temporary
Applicant	BIO TRACE MEDICAL, INC. 831 BRANSTEN RD, SUITE L SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	Laura N. Dietch Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	LDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2016
Decision Date	10/25/2016
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	N
Expedited Review