FDA 510(k)

TxRx Knee 15 Flare MR Coil 1.5T

Número K: K162966 · 2016-11-30

Data da decisão2016-11-30

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TxRx Knee 15 Flare MR Coil 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K162966. 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 TxRx Knee 15 Flare MR Coil 1.5T?

TxRx Knee 15 Flare MR Coil 1.5T is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K162966.

When did TxRx Knee 15 Flare MR Coil 1.5T receive FDA 510(k) clearance?

TxRx Knee 15 Flare MR Coil 1.5T received FDA 510(k) clearance on 2016-11-30, under 510(k) number K162966.

Who is the listed applicant for TxRx Knee 15 Flare MR Coil 1.5T?

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

What is the FDA product code for TxRx Knee 15 Flare MR Coil 1.5T?

The FDA product code for TxRx Knee 15 Flare MR Coil 1.5T is MOS.

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Fonte oficial

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