DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400— 510(k) K014255

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K014255 for DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400, Substantially Equivalent on 2002-07-02. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2001-12-26
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
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.