K092611 is an FDA 510(k) clearance for the SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901. This device is classified as a Airway Monitoring System (Class II - Special Controls, product code OQU).
Submitted by Sonarmed, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 28, 2010, 245 days after receiving the submission on August 26, 2009.
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 | K092611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2009 |
| Decision Date | April 28, 2010 |
| Days to Decision | 245 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 |