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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 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 |
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Every clearance here is in the API, with alerts when new ones post.