FDA 510(k)

MyoSPECT, MyoSpect ES

Número K: K212004 · 2021-08-27

Data da decisão2021-08-27

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MyoSPECT, MyoSpect ES is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K212004. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MyoSPECT, MyoSpect ES?

MyoSPECT, MyoSpect ES is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is GE Healthcare. The 510(k) number is K212004.

When did MyoSPECT, MyoSpect ES receive FDA 510(k) clearance?

MyoSPECT, MyoSpect ES received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212004.

Who is the listed applicant for MyoSPECT, MyoSpect ES?

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

What is the FDA product code for MyoSPECT, MyoSpect ES?

The FDA product code for MyoSPECT, MyoSpect ES is KPS.

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Fonte oficial

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