SonarMed AirWave Airway Monitoring System— 510(k) K193058

Name: FDA 510(k) clearance K193058
Creator: U.S. Food and Drug Administration
Published: 2020-05-15

Substantially Equivalent

Sonarmed, Inc.

FDA 510(k) clearance K193058 for SonarMed AirWave Airway Monitoring System, Substantially Equivalent on 2020-05-15. 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: 2019-11-01
Decision date: 2020-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

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