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510(k) K111988

EASYSCAN MODEL 1.2 by I-Optics BV — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2011
Date Received
July 13, 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

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