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510(k) K190989

6400 Ultrasound System (MyLabX6, MyLabX7) by Esaote, S.P.A. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2019
Date Received
April 15, 2019
Clearance Type
Special
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 Esaote, S.P.A.

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  • K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (May 16, 2025)
  • K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910) (June 26, 2024)
  • K230179 — 6440 MyLabX90 (November 29, 2023)
  • 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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