SonarMed AirWave Airway Monitoring System
FDA 510(k) clearance K193058 · decided 2020-05-15
Clearance details
- K-number
- K193058
- Device name
- SonarMed AirWave Airway Monitoring System
- Applicant
- Sonarmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-01
- Decision date
- 2020-05-15
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- OQU
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SonarMed AirWave, Airway Monitoring System (K143042) | Sonarmed, Inc. | 2016-01-22 |
| SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611) | Sonarmed, Inc. | 2010-04-28 |