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510(k) K230511

K3900 Ultrasound Imaging System by Maui Imaging — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2023
Date Received
February 24, 2023
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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