K200698 is an FDA 510(k) clearance for the Somnera System. This device is classified as a Positive Airway Pressure System (Class II - Special Controls, product code QBY).
Submitted by Fresca Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 29, 2020, 104 days after receiving the submission on March 17, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5273. A Positive Airway Pressure Delivery System Is A Prescription Noninvasive Ventilatory Device That Delivers Expiratory Positive Airway Pressure For Patients Suffering From Obstructive Sleep Apnea. The System Also Provides Positive Airway Pressure During Incipient Apnea. The System May Include A Dedicated Flow Generator And A Patient Interface..
| 510(k) Number | K200698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2020 |
| Decision Date | June 29, 2020 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QBY - Positive Airway Pressure System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5273 |
| Definition | A Positive Airway Pressure Delivery System Is A Prescription Noninvasive Ventilatory Device That Delivers Expiratory Positive Airway Pressure For Patients Suffering From Obstructive Sleep Apnea. The System Also Provides Positive Airway Pressure During Incipient Apnea. The System May Include A Dedicated Flow Generator And A Patient Interface. |