FDA 510(k)

MYLABTWICE, MODEL 6200

K-Number: K100931 · 2010-06-25

Decision Date2010-06-25

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MYLABTWICE, MODEL 6200 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K100931. 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 MYLABTWICE, MODEL 6200?

MYLABTWICE, MODEL 6200 is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Esaote, S.p.A.. The 510(k) number is K100931.

When did MYLABTWICE, MODEL 6200 receive FDA 510(k) clearance?

MYLABTWICE, MODEL 6200 received FDA 510(k) clearance on 2010-06-25, under 510(k) number K100931.

Who is the listed applicant for MYLABTWICE, MODEL 6200?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYLABTWICE, MODEL 6200?

The FDA product code for MYLABTWICE, MODEL 6200 is IYN.

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Other records listing Esaote, S.p.A. as applicant

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Related Devices (Code: IYN)

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.