FDA 510(k)

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil

Número K: K222257 · 2022-08-23

RequerenteInvivo Corporation (Business Trade Name: Philips)

Data da decisão2022-08-23

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil 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 2022-08-23 under 510(k) number K222257. 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 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K222257.

When did 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil receive FDA 510(k) clearance?

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil received FDA 510(k) clearance on 2022-08-23, under 510(k) number K222257.

Who is the listed applicant for 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

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 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

The FDA product code for 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil is MOS.

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Fonte oficial

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