510(k) K842184

SPOT-FILM DEVICE 8835 by General Electric Co. — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1984
Date Received
June 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type