FDA 510(k) Application Details - K013367

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K013367
Device Name	Electrocardiograph
Applicant	REYNOLDS MEDICAL LTD. 377 RT. 17 S. HASBROUCK HEIGHTS, NJ 07604 US Other 510(k) Applications for this Company
Contact	GEORGE MYERS Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2001
Decision Date	12/13/2001
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