FDA 510(k)

QuantumCam

Número K: K161674 · 2016-10-20

Data da decisão2016-10-20

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

QuantumCam is the device name listed in this FDA 510(k) record. The listed applicant is Ddd-Diagnostic A/S. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161674. 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 QuantumCam?

QuantumCam is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Ddd-Diagnostic A/S. The 510(k) number is K161674.

When did QuantumCam receive FDA 510(k) clearance?

QuantumCam received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161674.

Who is the listed applicant for QuantumCam?

The FDA 510(k) record lists Ddd-Diagnostic A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuantumCam?

The FDA product code for QuantumCam is KPS.

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