FDA 510(k)

Current Health Monitoring System Gen 2 (G2)

Número K: K210133 · 2021-09-03

Data da decisão2021-09-03

Código do produtoMSX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Current Health Monitoring System Gen 2 (G2) is the device name listed in this FDA 510(k) record. The listed applicant is Current Health. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K210133. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Current Health Monitoring System Gen 2 (G2)?

Current Health Monitoring System Gen 2 (G2) is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Current Health. The 510(k) number is K210133.

When did Current Health Monitoring System Gen 2 (G2) receive FDA 510(k) clearance?

Current Health Monitoring System Gen 2 (G2) received FDA 510(k) clearance on 2021-09-03, under 510(k) number K210133.

Who is the listed applicant for Current Health Monitoring System Gen 2 (G2)?

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

What is the FDA product code for Current Health Monitoring System Gen 2 (G2)?

The FDA product code for Current Health Monitoring System Gen 2 (G2) is MSX.

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