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FDA 510(k)

IMT.LAB SOFTWARE

K-Number: K062598 · 2006-10-31

ApplicantEsaote Europe B.V.
Decision Date2006-10-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMT.LAB SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Europe B.V.. It received FDA 510(k) clearance on 2006-10-31 under 510(k) number K062598. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMT.LAB SOFTWARE?

IMT.LAB SOFTWARE is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Esaote Europe B.V.. The 510(k) number is K062598.

When did IMT.LAB SOFTWARE receive FDA 510(k) clearance?

IMT.LAB SOFTWARE received FDA 510(k) clearance on 2006-10-31, under 510(k) number K062598.

Who is the listed applicant for IMT.LAB SOFTWARE?

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

What is the FDA product code for IMT.LAB SOFTWARE?

The FDA product code for IMT.LAB SOFTWARE is LLZ.

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Other records listing Esaote Europe B.V. as applicant

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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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