DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N— 510(k) K021435

Name: FDA 510(k) clearance K021435
Creator: U.S. Food and Drug Administration
Published: 2002-05-22

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K021435 for DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N, Substantially Equivalent on 2002-05-22. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2002-05-06
Decision date: 2002-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.