Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SonarMed AirWave, Airway Monitoring System

K-Number: K143042 · 2016-01-22

ApplicantSonarmed, Inc.
Decision Date2016-01-22
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 2016-01-22 under approval number K143042. 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 2016-01-22. It is manufactured by Sonarmed, Inc.. The 510(k) number is K143042.

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

SonarMed AirWave, Airway Monitoring System received FDA 510(k) clearance on 2016-01-22, under approval number K143042.

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

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Sonarmed, Inc.

K193058SonarMed AirWave Airway Monitoring System

Related Devices (Code: OQU)

K193058SonarMed 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.

↑