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510(k) K193058

Device
SonarMed AirWave Airway Monitoring System
Applicant
SonarMed, Inc.
510(k) number
K193058
Product code
OQU  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-15
Date received
2019-11-01
Regulation
868.5730
Classification name
Airway Monitoring System
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Laura Lyons
Address
12220 N. Meridian St., Suite 150 Carmel IN US 46032 46032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.2016-01-22
K092611SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901Sonarmed, Inc.2010-04-28

Legacy Summary#

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FDA Review#

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