Submission Details
| 510(k) Number | K241469 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2024 |
| Decision Date | June 15, 2024 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
Jun 2024
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K241469 is an FDA 510(k) clearance for the iQ 2 Nasal Vented Mask; Phantom 2 Nasal 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 June 15, 2024, 22 days after receiving the submission on May 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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