FDA 510(k)

Skylit Phototherapy System

Número K: K170489 · 2017-05-23

Data da decisão2017-05-23

Código do produtoFTC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Skylit Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Skylit Medical. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K170489. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Skylit Phototherapy System?

Skylit Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Skylit Medical. The 510(k) number is K170489.

When did Skylit Phototherapy System receive FDA 510(k) clearance?

Skylit Phototherapy System received FDA 510(k) clearance on 2017-05-23, under 510(k) number K170489.

Who is the listed applicant for Skylit Phototherapy System?

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

What is the FDA product code for Skylit Phototherapy System?

The FDA product code for Skylit Phototherapy System is FTC.

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Dispositivos Relacionados (Código: FTC)

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