FDA 510(k)

Next Generation NetKonnect

Número K: K220989 · 2022-07-29

RequerenteNihon Kohden Digital Health Solutions, Inc.

Data da decisão2022-07-29

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Next Generation NetKonnect is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Digital Health Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220989. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Next Generation NetKonnect?

Next Generation NetKonnect is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Nihon Kohden Digital Health Solutions, Inc.. The 510(k) number is K220989.

When did Next Generation NetKonnect receive FDA 510(k) clearance?

Next Generation NetKonnect received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220989.

Who is the listed applicant for Next Generation NetKonnect?

The FDA 510(k) record lists Nihon Kohden Digital Health Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Next Generation NetKonnect?

The FDA product code for Next Generation NetKonnect is MHX.

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