FDA 510(k)

MYLABSEVEN, MYLABALPHA

K-Number: K111302 · 2011-07-22

Decision Date2011-07-22

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MYLABSEVEN, MYLABALPHA 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 2011-07-22 under 510(k) number K111302. 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 MYLABSEVEN, MYLABALPHA?

MYLABSEVEN, MYLABALPHA is a medical device that received FDA 510(k) clearance on 2011-07-22. The listed applicant is Esaote, S.p.A.. The 510(k) number is K111302.

When did MYLABSEVEN, MYLABALPHA receive FDA 510(k) clearance?

MYLABSEVEN, MYLABALPHA received FDA 510(k) clearance on 2011-07-22, under 510(k) number K111302.

Who is the listed applicant for MYLABSEVEN, MYLABALPHA?

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 MYLABSEVEN, MYLABALPHA?

The FDA product code for MYLABSEVEN, MYLABALPHA is 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.