FDA 510(k)

Dosis SAM

Número K: K180410 · 2019-01-16

Data da decisão2019-01-16

Código do produtoMQS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dosis SAM is the device name listed in this FDA 510(k) record. The listed applicant is Dosis, Inc.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K180410. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dosis SAM?

Dosis SAM is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Dosis, Inc.. The 510(k) number is K180410.

When did Dosis SAM receive FDA 510(k) clearance?

Dosis SAM received FDA 510(k) clearance on 2019-01-16, under 510(k) number K180410.

Who is the listed applicant for Dosis SAM?

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

What is the FDA product code for Dosis SAM?

The FDA product code for Dosis SAM is MQS.

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Dispositivos Relacionados (Código: MQS)

K232283PhySoftAMS®Physician Software Systems, LLC

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