K221040 is an FDA 510(k) clearance for the Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Jiangxi Aicare Medical Technology Co., Ltd. (Fuzhou, CN). The FDA issued a Cleared decision on August 31, 2022, 146 days after receiving the submission on April 7, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K221040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2022 |
| Decision Date | August 31, 2022 |
| Days to Decision | 146 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 |