DINAMAP RESEARCH MONITOR 1245— 510(k) K800025

Substantially Equivalent

Applied Medical Research

FDA 510(k) clearance K800025 for DINAMAP RESEARCH MONITOR 1245, Substantially Equivalent on 1980-02-01. Applicant: Applied Medical Research.

Clearance details

Applicant: Applied Medical Research
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1980-01-07
Decision date: 1980-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.