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510(k) K161359

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System by Esaote, S.P.A. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2016
Date Received
May 16, 2016
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

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  • K212419 — Magnifico Open, Magnifico MSK (February 4, 2022)
  • K212021 — 6430 MyLabX75, 6430 MyLab XPro75 (September 16, 2021)
  • K192157 — 6450 Ultrasound system (November 22, 2019)
  • K191072 — 7410 Ultrasound System (MyLabSigma) (June 10, 2019)

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