FDA 510(k)

ViSi Mobile Monitoring System

Número K: K180472 · 2018-06-19

Data da decisão2018-06-19

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViSi Mobile Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sotera Wireless, Inc.. It received FDA 510(k) clearance on 2018-06-19 under 510(k) number K180472. 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 ViSi Mobile Monitoring System?

ViSi Mobile Monitoring System is a medical device that received FDA 510(k) clearance on 2018-06-19. The listed applicant is Sotera Wireless, Inc.. The 510(k) number is K180472.

When did ViSi Mobile Monitoring System receive FDA 510(k) clearance?

ViSi Mobile Monitoring System received FDA 510(k) clearance on 2018-06-19, under 510(k) number K180472.

Who is the listed applicant for ViSi Mobile Monitoring System?

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

What is the FDA product code for ViSi Mobile Monitoring System?

The FDA product code for ViSi Mobile Monitoring System is MHX.

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