ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR— 510(k) K923344

Substantially Equivalent

Citizen Watch Co., Ltd.

FDA 510(k) clearance K923344 for ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR, Substantially Equivalent on 1993-10-07. Applicant: Citizen Watch Co., Ltd..

Clearance details

Applicant: Citizen Watch Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1992-06-18
Decision date: 1993-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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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.