Product code OQU— Anesthesiology

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901

Classification name: Airway Monitoring System
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Total cleared: 3
First cleared: 2010-04-28
Most recent: 2020-05-15

FDA classification definition

“The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip”
— U.S. Food and Drug Administration, device classification record for product code OQU under 21 CFR 868.5730, via openFDA

Market context for product code OQU

FDA has cleared 3 devices under product code OQU between 2010 and 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20201 clearance
20161 clearance
20101 clearance

Top applicants under product code OQU

Sonarmed, Inc.3 clearances

Recent clearances under product code OQU

K193058 — SonarMed AirWave Airway Monitoring SystemSonarmed, Inc.·2020-05-15
K143042 — SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.·2016-01-22
K092611 — SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901Sonarmed, Inc.·2010-04-28

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