DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410— 510(k) K020022

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K020022 for DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410, Substantially Equivalent on 2002-02-01. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2002-01-03
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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.