SonarMed AirWave Airway Monitoring System

Airway Monitoring System

SonarMed, Inc.

The following data is part of a premarket notification filed by Sonarmed, Inc. with the FDA for Sonarmed Airwave Airway Monitoring System.

Pre-market Notification Details

Device IDK193058
510k NumberK193058
Device Name:SonarMed AirWave Airway Monitoring System
ClassificationAirway Monitoring System
Applicant SonarMed, Inc. 12220 N. Meridian St., Ste. 150 Carmel,  IN  46032
ContactLaura Lyons
CorrespondentLaura Lyons
SonarMed, Inc. 12220 N. Meridian St., Ste. 150 Carmel,  IN  46032
Product CodeOQU  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-05-15

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