Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor— 510(k) K210770

Substantially Equivalent

Andon Health Co, Ltd.

FDA 510(k) clearance K210770 for Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor, Substantially Equivalent on 2021-07-29. Applicant: Andon Health Co, Ltd..

Clearance details

Applicant: Andon Health Co, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2021-03-15
Decision date: 2021-07-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tianjin, 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.