FDA 510(k) Application Details - K955800

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K955800
Device Name	Electrode, Electrocardiograph
Applicant	CMC SENSE-IT, INC. 810 SOUTH 1ST. ST. #120 HOPKINS, MN 55343 US Other 510(k) Applications for this Company
Contact	CLARK VIWER Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1995
Decision Date	05/17/1996
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