510(k) K222887— Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor

Substantially Equivalent

Famidoc Technology Company Limited

Clearance details

Applicant: Famidoc Technology Company Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2022-09-23
Decision date: 2023-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, 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.