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510(k) DEN130051

PEDIATRIC VISION SCANNER by Rebiscan, Inc. — Product Code PMW

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 8, 2016
Date Received: December 13, 2013
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Strabismus Detection Device
Device Class: Class II
Regulation Number: 886.1342
Review Panel: OP
Submission Type

For the automated detection of misalignment of the visual axes for prescription use only.