K231728 is an FDA 510(k) clearance for the BiWaze Clear System. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Abmrc, LLC (Eagan, US). The FDA issued a Cleared decision on April 8, 2024, 300 days after receiving the submission on June 13, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K231728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2023 |
| Decision Date | April 08, 2024 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHJ — Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |