ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS— 510(k) K023100

Name: FDA 510(k) clearance K023100
Creator: U.S. Food and Drug Administration
Published: 2002-10-11

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K023100 for ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS, Substantially Equivalent on 2002-10-11. Applicant: General Electric Medical Systems Information Techn. Device class: 2.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-09-18
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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K020290 — DASH 3000/4000 PATIENT MONITOR2002-08-14
K021366 — MAC-LAB/CARDIOLAB EP/COMBOLAB2002-07-03

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.