OMRON DIGITAL BP MONITOR HEM-700C— 510(k) K853260

Substantially Equivalent

Omron Tateisi Electronics Co.

FDA 510(k) clearance K853260 for OMRON DIGITAL BP MONITOR HEM-700C, Substantially Equivalent on 1985-11-18. Applicant: Omron Tateisi Electronics Co..

Clearance details

Applicant: Omron Tateisi Electronics Co.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1985-08-02
Decision date: 1985-11-18
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.