YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J— 510(k) K081590

Substantially Equivalent

Ya Horng Electronic Co., Ltd.

FDA 510(k) clearance K081590 for YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J, Substantially Equivalent on 2008-06-19. Applicant: Ya Horng Electronic Co., Ltd..

Clearance details

Applicant: Ya Horng Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2008-06-06
Decision date: 2008-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nei Hu, Taipei, TW

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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.