FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT— 510(k) K093831

Substantially Equivalent

Health & Life Co., Ltd.

FDA 510(k) clearance K093831 for FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT, Substantially Equivalent on 2010-03-25. Applicant: Health & Life Co., Ltd..

Clearance details

Applicant: Health & Life Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-12-14
Decision date: 2010-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Chung Ho City, Taipei, Hsien, TW

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.