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FDA 510(k)

SonarMed AirWave Airway Monitoring System

K-Number: K193058 · 2020-05-15

ApplicantSonarmed, Inc.
Decision Date2020-05-15
Product CodeOQU
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SonarMed AirWave Airway Monitoring System is a medical device manufactured by Sonarmed, Inc.. It received FDA 510(k) clearance on 2020-05-15 under approval number K193058. The device is classified under product code OQU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SonarMed AirWave Airway Monitoring System?

SonarMed AirWave Airway Monitoring System is a medical device that received FDA 510(k) clearance on 2020-05-15. It is manufactured by Sonarmed, Inc.. The 510(k) number is K193058.

When was SonarMed AirWave Airway Monitoring System approved by the FDA?

SonarMed AirWave Airway Monitoring System received FDA 510(k) clearance on 2020-05-15, under approval number K193058.

What company makes SonarMed AirWave Airway Monitoring System?

SonarMed AirWave Airway Monitoring System is manufactured by Sonarmed, Inc..

What is the FDA product code for SonarMed AirWave Airway Monitoring System?

The FDA product code for SonarMed AirWave Airway Monitoring System is OQU.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Other Devices by Sonarmed, Inc.

K143042SonarMed AirWave, Airway Monitoring System

Related Devices (Code: OQU)

K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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