510(k) K840840

GENERATED RETINAL REFLEX IMAGERY SYS by Electro Optical Instruments — Product Code HKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retinoscope, Battery-Powered
Device Class
Class I
Regulation Number
886.1780
Review Panel
OP
Submission Type