The following data is part of a premarket notification filed by Sonarmed, Inc. with the FDA for Sonarmed Airwave Airway Monitoring System.
| Device ID | K193058 |
| 510k Number | K193058 |
| Device Name: | SonarMed AirWave Airway Monitoring System |
| Classification | Airway Monitoring System |
| Applicant | SonarMed, Inc. 12220 N. Meridian St., Ste. 150 Carmel, IN 46032 |
| Contact | Laura Lyons |
| Correspondent | Laura Lyons SonarMed, Inc. 12220 N. Meridian St., Ste. 150 Carmel, IN 46032 |
| Product Code | OQU |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-05-15 |