K193058 is an FDA 510(k) clearance for the SonarMed AirWave Airway Monitoring System. This device is classified as a Airway Monitoring System (Class II - Special Controls, product code OQU).
Submitted by Sonarmed, Inc. (Carmel, US). The FDA issued a Cleared decision on May 15, 2020, 196 days after receiving the submission on November 1, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730. The Device Is Intended To Assist In Verifying Ett Tube Placement, Assist In Detecting Ett Tube Movement And Obstruction Of The Tube Tip.
| 510(k) Number | K193058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2019 |
| Decision Date | May 15, 2020 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OQU - Airway Monitoring System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |
| Definition | The Device Is Intended To Assist In Verifying Ett Tube Placement, Assist In Detecting Ett Tube Movement And Obstruction Of The Tube Tip |