ViSi Mobile Monitoring System

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Sotera Wireless, Inc.

The following data is part of a premarket notification filed by Sotera Wireless, Inc. with the FDA for Visi Mobile Monitoring System.

Pre-market Notification Details

Device IDK150361
510k NumberK150361
Device Name:ViSi Mobile Monitoring System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Sotera Wireless, Inc. 10020 Huennekens Street San Diego,  CA  92121
ContactCarson Krupp
CorrespondentCarson Krupp
Sotera Wireless, Inc. 10020 Huennekens Street San Diego,  CA  92121
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-12
Decision Date2015-04-30
Summary:summary

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