510(k) K945580

DSP OPTION by Philips Medical Systems (Cleveland), Inc. — Product Code IZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type