MODIFICATION TO: UNITY NETWORK ID— 510(k) K071982

Name: FDA 510(k) clearance K071982
Creator: U.S. Food and Drug Administration
Published: 2007-09-21

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K071982 for MODIFICATION TO: UNITY NETWORK ID, Substantially Equivalent on 2007-09-21. 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: 2007-07-19
Decision date: 2007-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, 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.