CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)— 510(k) K133882

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K133882 for CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO), Substantially Equivalent on 2014-04-30. Applicant: Ge Medical Systems Information Technologies, Inc..

Clearance details

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2013-12-20
Decision date: 2014-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.