WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES— 510(k) K092558

Substantially Equivalent

Harvard Medical Devices , Ltd.

FDA 510(k) clearance K092558 for WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES, Substantially Equivalent on 2010-03-17. Applicant: Harvard Medical Devices , Ltd..

Clearance details

Applicant: Harvard Medical Devices , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-08-20
Decision date: 2010-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tsimshatsui, Kowloon, HK

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.