K241086 is an FDA 510(k) clearance for the Avidhrt Sense SpO2. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Avidhrt, Inc. (East Lansing, US). The FDA issued a Cleared decision on May 9, 2025, 385 days after receiving the submission on April 19, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K241086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2024 |
| Decision Date | May 09, 2025 |
| Days to Decision | 385 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 |