BP 101 DIGITAL BLOOD PRESSURE MONITOR— 510(k) K062033

Substantially Equivalent

Kingyield Hongkong Limited

FDA 510(k) clearance K062033 for BP 101 DIGITAL BLOOD PRESSURE MONITOR, Substantially Equivalent on 2007-03-23. Applicant: Kingyield Hongkong Limited.

Clearance details

Applicant: Kingyield Hongkong Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-07-18
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Point, 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.