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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 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.

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. 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.

Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

Official Source

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

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