Home / 510(k) Clearances / K231659

510(k) K231659

MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) by Medisono — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2024
Date Received
June 7, 2023
Clearance Type
Traditional
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

Other clearances by Medisono

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  • K163688 — Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (February 23, 2017)

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