MouthLab Vital Signs Monitoring System

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

MultiSensor Diagnostics (dba Aidar Health)

The following data is part of a premarket notification filed by Multisensor Diagnostics (dba Aidar Health) with the FDA for Mouthlab Vital Signs Monitoring System.

Pre-market Notification Details

Device IDK201635
510k NumberK201635
Device Name:MouthLab Vital Signs Monitoring System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant MultiSensor Diagnostics (dba Aidar Health) 3402 Birch Hollow Rd. Pikesville,  MD  21208
ContactSathya Elumalai
CorrespondentAllison C. Komiyama
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeMWI  
Subsequent Product CodeBZH
Subsequent Product CodeBZQ
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2021-02-06

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