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FDA 510(k)

ViSi Mobile Monitoring System

K-Number: K180472 · 2018-06-19

ApplicantSotera Wireless, Inc.
Decision Date2018-06-19
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViSi Mobile Monitoring System is a medical device manufactured by Sotera Wireless, Inc.. It received FDA 510(k) clearance on 2018-06-19 under approval number K180472. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Sotera Wireless, Inc.. The 510(k) number is K180472.

When was ViSi Mobile Monitoring System approved by the FDA?

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

What company makes ViSi Mobile Monitoring System?

ViSi Mobile Monitoring System is manufactured by Sotera Wireless, Inc..

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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Related PubMed Literature

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Related Devices (Code: MHX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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