FDA 510(k)

SmartByte Device

Número K: K171165 · 2017-05-18

Data da decisão2017-05-18

Código do produtoONY

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartByte Device is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Intake. It received FDA 510(k) clearance on 2017-05-18 under 510(k) number K171165. The device is classified under product code ONY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartByte Device?

SmartByte Device is a medical device that received FDA 510(k) clearance on 2017-05-18. The listed applicant is Scientific Intake. The 510(k) number is K171165.

When did SmartByte Device receive FDA 510(k) clearance?

SmartByte Device received FDA 510(k) clearance on 2017-05-18, under 510(k) number K171165.

Who is the listed applicant for SmartByte Device?

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

What is the FDA product code for SmartByte Device?

The FDA product code for SmartByte Device is ONY.

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