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FDA 510(k)

MODIFICATION TO E-SCAN XQ

K-Number: K032121 · 2003-08-13

ApplicantEsaote, S.p.A.
Decision Date2003-08-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO E-SCAN XQ 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 2003-08-13 under 510(k) number K032121. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO E-SCAN XQ?

MODIFICATION TO E-SCAN XQ is a medical device that received FDA 510(k) clearance on 2003-08-13. The listed applicant is Esaote, S.p.A.. The 510(k) number is K032121.

When did MODIFICATION TO E-SCAN XQ receive FDA 510(k) clearance?

MODIFICATION TO E-SCAN XQ received FDA 510(k) clearance on 2003-08-13, under 510(k) number K032121.

Who is the listed applicant for MODIFICATION TO E-SCAN XQ?

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 MODIFICATION TO E-SCAN XQ?

The FDA product code for MODIFICATION TO E-SCAN XQ is LNH.

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Related Devices (Code: LNH)

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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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