510(k) K112880

CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE by Freedom Meditech, Inc. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2013
Date Received
September 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type