MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901— 510(k) K071384

Substantially Equivalent

Nihon Seimitsu Sokki Co., Ltd.

FDA 510(k) clearance K071384 for MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901, Substantially Equivalent on 2007-10-09. Applicant: Nihon Seimitsu Sokki Co., Ltd..

Clearance details

Applicant: Nihon Seimitsu Sokki Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2007-05-17
Decision date: 2007-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tachikawa-Shi, Tokyo, JP

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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.