510(k) K884661

D-SCOPE III by Medx, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
November 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type