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 ↗

Recent devices under product code OQU

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K193058 — SonarMed AirWave Airway Monitoring System2020-05-15
K092611 — SONARMED AIRWAY MONITORING SYSTEM, MODEL 09012010-04-28

Recalls naming K143042

K-number listed on FDA's recall record

Z-2450-2019 — SonarMed AirWave Monitor, Model Number M0001Class II·Terminated·SonarMed Inc·20170417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143042.

Data sourced from openFDA. This site is unofficial and independent of the FDA.