Upper Arm Blood Pressure Monitor— 510(k) K191673

Substantially Equivalent

Famidoc Technology Company Limited

FDA 510(k) clearance K191673 for Upper Arm Blood Pressure Monitor, Substantially Equivalent on 2019-11-27. Applicant: Famidoc Technology Company Limited.

Clearance details

Applicant: Famidoc Technology Company Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2019-06-24
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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.