510(k) K970640

PHILIPS EASY DIAGNOST by Philips Medical Systems North America, Inc. — Product Code IXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1997
Date Received
February 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type