Vitals360 Multi-Vitals Mobile Monitor

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

VoCare, Inc.

The following data is part of a premarket notification filed by Vocare, Inc. with the FDA for Vitals360 Multi-vitals Mobile Monitor.

Pre-market Notification Details

Device IDK210086
510k NumberK210086
Device Name:Vitals360 Multi-Vitals Mobile Monitor
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant VoCare, Inc. 4950 Turkey Foot Road Zionsville,  IN  46077
ContactSteve Peabody
CorrespondentDeon Vigilance
VoCare, Inc. 4950 Turkey Foot Road Zionsville,  IN  46077
Product CodeMWI  
Subsequent Product CodeDQA
Subsequent Product CodeDSH
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-13
Decision Date2021-05-20

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