SonarMed AirWave, Airway Monitoring System
FDA 510(k) clearance K143042 · decided 2016-01-22
Clearance details
- K-number
- K143042
- Device name
- SonarMed AirWave, Airway Monitoring System
- Applicant
- Sonarmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-22
- Decision date
- 2016-01-22
- Days to decision
- 457 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 (K193058) | Sonarmed, Inc. | 2020-05-15 |
| SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611) | Sonarmed, Inc. | 2010-04-28 |
Recalls involving this device
No recalls on record reference this clearance.