FDA 510(k)

Philips Incisive CT on Trailer

Número K: K211168 · 2021-11-22

RequerentePhilips Healthcare (Suzhou) Co., Ltd.

Data da decisão2021-11-22

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips Incisive CT on Trailer is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K211168. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips Incisive CT on Trailer?

Philips Incisive CT on Trailer is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K211168.

When did Philips Incisive CT on Trailer receive FDA 510(k) clearance?

Philips Incisive CT on Trailer received FDA 510(k) clearance on 2021-11-22, under 510(k) number K211168.

Who is the listed applicant for Philips Incisive CT on Trailer?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Incisive CT on Trailer?

The FDA product code for Philips Incisive CT on Trailer is JAK.

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