OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR— 510(k) K880572

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K880572 for OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR, Substantially Equivalent on 1988-05-10. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1988-02-11
Decision date: 1988-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.