K222658 is an FDA 510(k) clearance for the Accurate 24 Non-invasive blood pressure monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Accurate Meditech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on June 21, 2023, 292 days after receiving the submission on September 2, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K222658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2022 |
| Decision Date | June 21, 2023 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |