FDA 510(k)

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

N.º K: K232021 · 2023-09-01

SolicitantePhilips Healthcare (Suzhou) Co., Ltd.

Fecha de decisión2023-09-01

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T 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 2023-09-01 under 510(k) number K232021. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232021.

When did Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T receive FDA 510(k) clearance?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232021.

Who is the listed applicant for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

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 TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

The FDA product code for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is MOS.

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Otros registros que enlistan a Philips Healthcare (Suzhou) Co., Ltd. como solicitante

K252992CT Rembra RT; CT Areta RT; CT Rembra K260519Smart Fit TorsoCardiac 1.5T K242329CT Collaboration Live K232491CT 5300 K233600Smart Fit Knee 3.0T K223311Philips CT 3500

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Dispositivos relacionados (Código: MOS)

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Fuente oficial

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