FDA 510(k) Application Details - K982975

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K982975
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	DATRIX 316 STATE PLACE ESCONDIDO, CA 92029 US Other 510(k) Applications for this Company
Contact	JON BARRON Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/1998
Decision Date	11/10/1998
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