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510(k) K212851

EchoSK and EchoSGyn modules for EchoS Family devices by Echolight S.P.A — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2022
Date Received
September 7, 2021
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

Other clearances by Echolight S.P.A

  • K202514 — EchoS Family (February 25, 2021)
  • K180516 — EchoS (October 19, 2018)

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