K251102 is an FDA 510(k) clearance for the Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Cemho Medical Technology (Guangdong) Co., Ltd. (Meizhou City, CN). The FDA issued a Cleared decision on July 16, 2025, 96 days after receiving the submission on April 11, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K251102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2025 |
| Decision Date | July 16, 2025 |
| Days to Decision | 96 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 |