FDA 510(k)

ClearVision ExamVue Flat Panel Detector

Número K: K160143 · 2016-10-28

Data da decisão2016-10-28

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearVision ExamVue Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K160143. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearVision ExamVue Flat Panel Detector?

ClearVision ExamVue Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Jpi Healthcare, Inc.. The 510(k) number is K160143.

When did ClearVision ExamVue Flat Panel Detector receive FDA 510(k) clearance?

ClearVision ExamVue Flat Panel Detector received FDA 510(k) clearance on 2016-10-28, under 510(k) number K160143.

Who is the listed applicant for ClearVision ExamVue Flat Panel Detector?

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

What is the FDA product code for ClearVision ExamVue Flat Panel Detector?

The FDA product code for ClearVision ExamVue Flat Panel Detector is MQB.

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