The following data is part of a premarket notification filed by Sonarmed, Inc. with the FDA for Sonarmed Airwave, Airway Monitoring System.
| Device ID | K143042 |
| 510k Number | K143042 |
| 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 | 2014-10-22 |
| Decision Date | 2016-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851334007111 | K143042 | 000 |
| 20851334007012 | K143042 | 000 |
| 20851334007029 | K143042 | 000 |
| 20851334007036 | K143042 | 000 |
| 20851334007043 | K143042 | 000 |
| 20851334007050 | K143042 | 000 |
| 20851334007067 | K143042 | 000 |
| 00851334007070 | K143042 | 000 |
| 20851334007081 | K143042 | 000 |
| 20851334007098 | K143042 | 000 |
| 20851334007104 | K143042 | 000 |
| 00851334007001 | K143042 | 000 |