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510(k) K163688

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 by Medisono, LLC — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
December 28, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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