K240305 is an FDA 510(k) clearance for the ANNE Limb. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on May 28, 2024, 116 days after receiving the submission on February 2, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K240305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2024 |
| Decision Date | May 28, 2024 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |