SonarMed AirWave, Airway Monitoring System— 510(k) K143042

Name: FDA 510(k) clearance K143042
Creator: U.S. Food and Drug Administration
Published: 2016-01-22

Substantially Equivalent

Sonarmed, Inc.

FDA 510(k) clearance K143042 for SonarMed AirWave, Airway Monitoring System, Substantially Equivalent on 2016-01-22. Applicant: Sonarmed, Inc.. Device class: 2.

Clearance details

Applicant: Sonarmed, Inc.
Product code: Code OQU
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Date received: 2014-10-22
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

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