OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C— 510(k) K881601

Substantially Equivalent

Omron Tateisi Electronics Co.

FDA 510(k) clearance K881601 for OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C, Substantially Equivalent on 1988-06-15. Applicant: Omron Tateisi Electronics Co..

Clearance details

Applicant: Omron Tateisi Electronics Co.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1988-04-13
Decision date: 1988-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, 105 Japan, 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.