K022193

Substantially Equivalent

DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N

Applicant: Ge Medical Systems Information Technologies
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2002-07-05
Decision date: 2002-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampa, FL, US

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.