FDA 510(k)

Smart Fit Knee 3.0T

Número K: K233600 · 2024-02-05

RequerentePhilips Healthcare (Suzhou) Co., Ltd.

Data da decisão2024-02-05

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Fit Knee 3.0T 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 2024-02-05 under 510(k) number K233600. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Fit Knee 3.0T?

Smart Fit Knee 3.0T is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K233600.

When did Smart Fit Knee 3.0T receive FDA 510(k) clearance?

Smart Fit Knee 3.0T received FDA 510(k) clearance on 2024-02-05, under 510(k) number K233600.

Who is the listed applicant for Smart Fit Knee 3.0T?

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 Smart Fit Knee 3.0T?

The FDA product code for Smart Fit Knee 3.0T is MOS.

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Outros registros que listam Philips Healthcare (Suzhou) Co., Ltd. como candidato(a)

K252992CT Rembra RT; CT Areta RT; CT Rembra K260519Smart Fit TorsoCardiac 1.5T K242329CT Collaboration Live K232491CT 5300 K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T K223311Philips CT 3500

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Fonte oficial

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