K021435

Substantially Equivalent

DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N

Applicant: Ge Medical Systems Information Technologies
Product code: MWI
Advisory panel: Cardiovascular
Date received: 2002-05-06
Decision date: 2002-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

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.