FDA 510(k)

ds Head 32ch 3.0T

Número K: K213351 · 2021-10-29

RequerenteInvivo Corporation (Business Trade Name: Philips)

Data da decisão2021-10-29

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ds Head 32ch 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213351. 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 ds Head 32ch 3.0T?

ds Head 32ch 3.0T is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213351.

When did ds Head 32ch 3.0T receive FDA 510(k) clearance?

ds Head 32ch 3.0T received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213351.

Who is the listed applicant for ds Head 32ch 3.0T?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ds Head 32ch 3.0T?

The FDA product code for ds Head 32ch 3.0T is MOS.

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Fonte oficial

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