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510(k) K102027

AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM by Quantel Medical S.A. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2010
Date Received
July 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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