OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C— 510(k) K903134

Substantially Equivalent

Omron Marshall Products, Inc.

FDA 510(k) clearance K903134 for OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C, Substantially Equivalent on 1991-01-08. Applicant: Omron Marshall Products, Inc..

Clearance details

Applicant: Omron Marshall Products, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1990-07-17
Decision date: 1991-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, 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.