FDA 510(k)

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

Número K: K202679 · 2021-04-12

Data da decisão2021-04-12

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K202679. 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 Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Mcgovern Medical School. The 510(k) number is K202679.

When did Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 receive FDA 510(k) clearance?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 received FDA 510(k) clearance on 2021-04-12, under 510(k) number K202679.

Who is the listed applicant for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

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

What is the FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

The FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is KPS.

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Outros registros que listam Mcgovern Medical School como candidato(a)

K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

Dispositivos Relacionados (Código: KPS)

Fonte oficial

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