Atlas FDA

OQU

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Airway Monitoring System
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5730
Medical specialty
Anesthesiology
FDA definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SonarMed AirWave Airway Monitoring System (K193058)Sonarmed, Inc.2020-05-15
SonarMed AirWave, Airway Monitoring System (K143042)Sonarmed, Inc.2016-01-22
SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611)Sonarmed, Inc.2010-04-28

Track OQU automatically

Every clearance here is in the API, with alerts when new ones post.