FDA 510(k)

DynoSense Vital Sign Measuring System

Número K: K190090 · 2019-08-02

Data da decisão2019-08-02

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DynoSense Vital Sign Measuring System is the device name listed in this FDA 510(k) record. The listed applicant is Dynosense Corp.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K190090. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DynoSense Vital Sign Measuring System?

DynoSense Vital Sign Measuring System is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Dynosense Corp.. The 510(k) number is K190090.

When did DynoSense Vital Sign Measuring System receive FDA 510(k) clearance?

DynoSense Vital Sign Measuring System received FDA 510(k) clearance on 2019-08-02, under 510(k) number K190090.

Who is the listed applicant for DynoSense Vital Sign Measuring System?

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

What is the FDA product code for DynoSense Vital Sign Measuring System?

The FDA product code for DynoSense Vital Sign Measuring System is MWI.

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