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 IDK112478
510k NumberK112478
Device Name:VISI MOBILE MONITORING SYSTEM
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant SOTERA WIRELESS, INC 9444 WAPLES STREET San Diego,  CA  92121
ContactEben Gordon
CorrespondentEben Gordon
SOTERA WIRELESS, INC 9444 WAPLES STREET San Diego,  CA  92121
Product CodeMWI  
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-29
Decision Date2012-03-22
Summary:summary

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