K250136 is an FDA 510(k) clearance for the Globalcare Blood Pressure Monitor (GUS610). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Globalcare Medical Technology Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 8, 2025, 81 days after receiving the submission on January 17, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K250136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2025 |
| Decision Date | April 08, 2025 |
| Days to Decision | 81 days |
| Submission Type | Special |
| 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 |