FDA 510(k)

iMac 27 & PL 4.0

Número K: K200889 · 2020-06-02

Data da decisão2020-06-02

Código do produtoPGY

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

iMac 27 & PL 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Quantum-Spectra, LLC. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200889. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iMac 27 & PL 4.0?

iMac 27 & PL 4.0 is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Quantum-Spectra, LLC. The 510(k) number is K200889.

When did iMac 27 & PL 4.0 receive FDA 510(k) clearance?

iMac 27 & PL 4.0 received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200889.

Who is the listed applicant for iMac 27 & PL 4.0?

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

What is the FDA product code for iMac 27 & PL 4.0?

The FDA product code for iMac 27 & PL 4.0 is PGY.

Dispositivos Relacionados (Código: PGY)

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