FDA 510(k)

eWave Monitor

Número K: K214073 · 2022-10-20

Data da decisão2022-10-20

Código do produtoDSH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

eWave Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Wearlinq, Inc.. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K214073. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the eWave Monitor?

eWave Monitor is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Wearlinq, Inc.. The 510(k) number is K214073.

When did eWave Monitor receive FDA 510(k) clearance?

eWave Monitor received FDA 510(k) clearance on 2022-10-20, under 510(k) number K214073.

Who is the listed applicant for eWave Monitor?

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

What is the FDA product code for eWave Monitor?

The FDA product code for eWave Monitor is DSH.

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