510(k) K790637

COMPUTERIZED ELECTRO-OCULOGRAPH by Potomac Medical System — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1979
Date Received
April 2, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
Submission Type