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510(k) K171528

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) by Avantsonic Technology Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2018
Date Received
May 25, 2017
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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