FDA 510(k)

LOCATOR R-Tx

Número K: K200827 · 2020-09-02

Data da decisão2020-09-02

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOCATOR R-Tx is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Super Holdco, Incp.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200827. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LOCATOR R-Tx?

LOCATOR R-Tx is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Ivory Super Holdco, Incp.. The 510(k) number is K200827.

When did LOCATOR R-Tx receive FDA 510(k) clearance?

LOCATOR R-Tx received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200827.

Who is the listed applicant for LOCATOR R-Tx?

The FDA 510(k) record lists Ivory Super Holdco, Incp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOCATOR R-Tx?

The FDA product code for LOCATOR R-Tx is NHA.

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Fonte oficial

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