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510(k) K212021

6430 MyLabX75, 6430 MyLab XPro75 by Esaote, S.P.A. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2021
Date Received
June 28, 2021
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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