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 IDK143042
510k NumberK143042
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 Received2014-10-22
Decision Date2016-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20851334007111 K143042 000
20851334007012 K143042 000
20851334007029 K143042 000
20851334007036 K143042 000
20851334007043 K143042 000
20851334007050 K143042 000
20851334007067 K143042 000
00851334007070 K143042 000
20851334007081 K143042 000
20851334007098 K143042 000
20851334007104 K143042 000
00851334007001 K143042 000

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