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FDA 510(k)

MyLabSix Ultrasound System

K-Number: K161168 · 2016-09-02

ApplicantEsaote Europe B.V.
Decision Date2016-09-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyLabSix Ultrasound System is a medical device manufactured by Esaote Europe B.V.. It received FDA 510(k) clearance on 2016-09-02 under approval number K161168. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyLabSix Ultrasound System?

MyLabSix Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Esaote Europe B.V.. The 510(k) number is K161168.

When was MyLabSix Ultrasound System approved by the FDA?

MyLabSix Ultrasound System received FDA 510(k) clearance on 2016-09-02, under approval number K161168.

What company makes MyLabSix Ultrasound System?

MyLabSix Ultrasound System is manufactured by Esaote Europe B.V..

What is the FDA product code for MyLabSix Ultrasound System?

The FDA product code for MyLabSix Ultrasound System is IYN.

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Related Devices (Code: IYN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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