510(k) K251102— Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)

Substantially Equivalent

Cemho Medical Technology (Guangdong) Co., Ltd.

Clearance details

Applicant: Cemho Medical Technology (Guangdong) Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2025-04-11
Decision date: 2025-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meizhou City, CN

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.