K223747 is an FDA 510(k) clearance for the Whitsundays Mask System. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Resmed Pty Ltd (Registration Number: 3004604967) (Bella Vista, AU). The FDA issued a Cleared decision on July 6, 2023, 204 days after receiving the submission on December 14, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K223747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2022 |
| Decision Date | July 06, 2023 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD - Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |