K232588 is an FDA 510(k) clearance for the Aluna 2. This device is classified as a Meter, Peak Flow, Spirometry (Class II - Special Controls, product code BZH).
Submitted by Knox Medical Diagnostics (San Francisco, US). The FDA issued a Cleared decision on November 25, 2024, 458 days after receiving the submission on August 25, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K232588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | November 25, 2024 |
| Days to Decision | 458 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZH - Meter, Peak Flow, Spirometry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1860 |