Submission Details
| 510(k) Number | K190533 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 2019 |
| Decision Date | July 26, 2019 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
Jul 2019
Decision
144d
Days
Class 2
Risk
About This 510(k) Submission
K190533 is an FDA 510(k) clearance for the Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on July 26, 2019, 144 days after receiving the submission on March 4, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.
Device Classification
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
Manufacturer
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