Cleared Traditional

MYLABSEVEN, MYLABALPHA

K142008 · Esaote, S.P.A. · Radiology
Sep 2014
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K142008 is an FDA 510(k) clearance for the MYLABSEVEN, MYLABALPHA, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on September 12, 2014, 51 days after receiving the submission on July 23, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K142008 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2014
Decision Date September 12, 2014
Days to Decision 51 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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