The following data is part of a premarket notification filed by Sonarmed, Inc. with the FDA for Sonarmed Airway Monitoring System, Model 0901.
| Device ID | K092611 |
| 510k Number | K092611 |
| Device Name: | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 |
| Classification | Airway Monitoring System |
| Applicant | SONARMED, INC. 5513 WEST 74TH ST. Indianapolis, IN 46268 |
| Contact | Laura Lyons |
| Correspondent | Laura Lyons SONARMED, INC. 5513 WEST 74TH ST. Indianapolis, IN 46268 |
| Product Code | OQU |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2010-04-28 |
| Summary: | summary |