FDA 510(k)

QFR (3.0)

Número K: K243769 · 2025-04-04

Data da decisão2025-04-04

Código do produtoQHA

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

QFR (3.0) is the device name listed in this FDA 510(k) record. The listed applicant is Qfr Solutions BV. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K243769. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the QFR (3.0)?

QFR (3.0) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Qfr Solutions BV. The 510(k) number is K243769.

When did QFR (3.0) receive FDA 510(k) clearance?

QFR (3.0) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243769.

Who is the listed applicant for QFR (3.0)?

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

What is the FDA product code for QFR (3.0)?

The FDA product code for QFR (3.0) is QHA.

Dispositivos Relacionados (Código: QHA)

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