FDA 510(k)

Xerosyn

Número K: K233259 · 2024-06-21

Data da decisão2024-06-21

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xerosyn is the device name listed in this FDA 510(k) record. The listed applicant is Xerothera, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233259. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Xerosyn?

Xerosyn is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Xerothera, Inc.. The 510(k) number is K233259.

When did Xerosyn receive FDA 510(k) clearance?

Xerosyn received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233259.

Who is the listed applicant for Xerosyn?

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

What is the FDA product code for Xerosyn?

The FDA product code for Xerosyn is MQV.

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Fonte oficial

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