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FDA 510(k)

MYLABGOLD

K-Number: K110688 · 2011-06-02

ApplicantEsaote
Decision Date2011-06-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYLABGOLD is the device name listed in this FDA 510(k) record. The listed applicant is Esaote. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K110688. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYLABGOLD?

MYLABGOLD is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Esaote. The 510(k) number is K110688.

When did MYLABGOLD receive FDA 510(k) clearance?

MYLABGOLD received FDA 510(k) clearance on 2011-06-02, under 510(k) number K110688.

Who is the listed applicant for MYLABGOLD?

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

What is the FDA product code for MYLABGOLD?

The FDA product code for MYLABGOLD is IYO.

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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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