cNEP Airway
FDA 510(k) clearance DEN140024 · decided 2015-12-23
Clearance details
- K-number
- DEN140024
- Device name
- cNEP Airway
- Applicant
- Sommetrics
- Decision
- Unknown
- Date received
- 2014-08-18
- Decision date
- 2015-12-23
- Days to decision
- 492 days
- Clearance type
- Direct
- Product code
- PMB
- Device class
- 2
- Regulation number
- 868.5105
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.