CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION— 510(k) K032370

Name: FDA 510(k) clearance K032370
Creator: U.S. Food and Drug Administration
Published: 2003-08-13

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K032370 for CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION, Substantially Equivalent on 2003-08-13. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2003-08-01
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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K231276 — SmartCardia 7L Platform2023-08-30

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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 →

Recalls naming K032370

K-number listed on FDA's recall record

Z-0726-2020 — CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.Class II·Terminated·GE Healthcare, LLC·20191112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032370.

Data sourced from openFDA. This site is unofficial and independent of the FDA.