Cleared Traditional

6430 MyLabX75, 6430 MyLab XPro75

K212021 · Esaote, S.P.A. · Radiology
Sep 2021
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K212021 is an FDA 510(k) clearance for the 6430 MyLabX75, 6430 MyLab XPro75, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Genoa, IT). The FDA issued a Cleared decision on September 16, 2021, 80 days after receiving the submission on June 28, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K212021 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2021
Decision Date September 16, 2021
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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