FDA 510(k) Application Details - K950988

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K950988
Device Name	Computer, Diagnostic, Programmable
Applicant	OMEGA MEDICAL SERVICES, INC. 12811 KENWOOD LANE, SUITE 203 FT. MYERS, FL 33907 US Other 510(k) Applications for this Company
Contact	ROBERT N GRANTHAM 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	03/03/1995
Decision Date	01/04/1996
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