510(k) K170470

Digital Eye Anterior Camera by Medimaging Integrated Solution, Inc (Miis) — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2017
Date Received
February 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type