FDA 510(k)

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

N.º K: K212864 · 2021-12-01

SolicitantePhilips Healthcare (Suzhou) Co., Ltd.

Fecha de decisión2021-12-01

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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 2021-12-01 under 510(k) number K212864. 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212864.

When did dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T receive FDA 510(k) clearance?

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212864.

Who is the listed applicant for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T?

The FDA product code for dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 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 K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

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Fuente oficial

Ver en la base de datos de la FDA →

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