iHealth View BP7S Wireless Blood Pressure Wrist Monitor— 510(k) K152379

Substantially Equivalent

Andon Health Co, Ltd.

FDA 510(k) clearance K152379 for iHealth View BP7S Wireless Blood Pressure Wrist Monitor, Substantially Equivalent on 2015-09-23. Applicant: Andon Health Co, Ltd..

Clearance details

Applicant: Andon Health Co, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-08-21
Decision date: 2015-09-23
Decision: Substantially Equivalent
Clearance type: Special
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.