FDA 510(k)

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

Número K: K181016 · 2018-07-16

Data da decisão2018-07-16

Código do produtoNFJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K181016. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K181016.

When did Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System receive FDA 510(k) clearance?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181016.

Who is the listed applicant for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

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

What is the FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

The FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is NFJ.

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