FDA 510(k)

Localite TMS Navigator TS

Numéro K : K223577 · 2023-04-17

Date de décision2023-04-17

Code produitHAW

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Localite TMS Navigator TS is the device name listed in this FDA 510(k) record. The listed applicant is Localite GmbH. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K223577. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Localite TMS Navigator TS?

Localite TMS Navigator TS is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Localite GmbH. The 510(k) number is K223577.

When did Localite TMS Navigator TS receive FDA 510(k) clearance?

Localite TMS Navigator TS received FDA 510(k) clearance on 2023-04-17, under 510(k) number K223577.

Who is the listed applicant for Localite TMS Navigator TS?

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

What is the FDA product code for Localite TMS Navigator TS?

The FDA product code for Localite TMS Navigator TS is HAW.

Essais cliniques associés

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Source officielle

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