Submission Details
| 510(k) Number | K241830 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
Oct 2024
Decision
116d
Days
Class 2
Risk
About This 510(k) Submission
K241830 is an FDA 510(k) clearance for the Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on October 18, 2024, 116 days after receiving the submission on June 24, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.
Device Classification
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5905 |
Manufacturer
Similar Devices — BZD Ventilator, Non-continuous (respirator)
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