FDA 510(k)

1.5T e 3.0T 16 CH Braços de Cisalhamento GE de Ombro

Número K: K162001 · 2016-08-31

Data da decisão2016-08-31

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

1.5T and 3.0T 16 CH GE Shoulder Coils is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K162001. 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 1.5T and 3.0T 16 CH GE Shoulder Coils?

1.5T and 3.0T 16 CH GE Shoulder Coils is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Invivo Corporation. The 510(k) number is K162001.

When did 1.5T and 3.0T 16 CH GE Shoulder Coils receive FDA 510(k) clearance?

1.5T and 3.0T 16 CH GE Shoulder Coils received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162001.

Who is the listed applicant for 1.5T and 3.0T 16 CH GE Shoulder Coils?

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

What is the FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils?

The FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils is MOS.

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