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FDA 510(k)

SONOLITH I-MOVE

K-Number: K111808 · 2011-08-01

ApplicantEdap Tms France
Decision Date2011-08-01
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SONOLITH I-MOVE is the device name listed in this FDA 510(k) record. The listed applicant is Edap Tms France. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K111808. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLITH I-MOVE?

SONOLITH I-MOVE is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Edap Tms France. The 510(k) number is K111808.

When did SONOLITH I-MOVE receive FDA 510(k) clearance?

SONOLITH I-MOVE received FDA 510(k) clearance on 2011-08-01, under 510(k) number K111808.

Who is the listed applicant for SONOLITH I-MOVE?

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

What is the FDA product code for SONOLITH I-MOVE?

The FDA product code for SONOLITH I-MOVE is LNS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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