510(k) K053425

PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS by Precision Optics Corp. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2006
Date Received
December 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type