SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
FDA 510(k) clearance K092611 · decided 2010-04-28
Clearance details
- K-number
- K092611
- Device name
- SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
- Applicant
- Sonarmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-26
- Decision date
- 2010-04-28
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- OQU
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, 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 AirWave, Airway Monitoring System (K143042) | Sonarmed, Inc. | 2016-01-22 |
Recalls involving this device
No recalls on record reference this clearance.