FDA 510(k) Application Details - K951902

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K951902
Device Name	Computer, Diagnostic, Programmable
Applicant	REYNOLDS MEDICAL LTD. 201 ROUTE 17 RUTHERFORD, NJ 07070 US Other 510(k) Applications for this Company
Contact	GEORGE MYERS Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1995
Decision Date	07/15/1996
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