FDA 510(k)

1.5T 16ch Braço de Cisalhamento de Ombro, 3.0T 16ch Braço de Cisalhamento de Ombro

Número K: K201101 · 2020-06-02

Data da decisão2020-06-02

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K201101. 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 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Neocoil, LLC. The 510(k) number is K201101.

When did 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil receive FDA 510(k) clearance?

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil received FDA 510(k) clearance on 2020-06-02, under 510(k) number K201101.

Who is the listed applicant for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

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

What is the FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil?

The FDA product code for 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil is MOS.

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Fonte oficial

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