MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM— 510(k) K001305

Clearance details

Applicant

General Electric Medical Systems Information Techn

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2000-04-24

Decision date

2000-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sugarland, TX, US

• K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
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• K253576 — CorVista System® with PCWP Add-On2026-07-26
• K262006 — EnSite X EP System2026-07-15
• K252978 — ScioCardio ECG Analysis Platform2026-07-09

• K023380 — T-WAVE ALTERMANS (TWA) ALGORITHM OPTION2002-12-03
• K021470 — SEER LIGHT COMPACT DIGITAL HOLTER RECORDER2002-11-14
• K023100 — ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS2002-10-11
• K021454 — UNITY NETWORK ID2002-10-01
• K020290 — DASH 3000/4000 PATIENT MONITOR2002-08-14

Death

10

Injury

225

Malfunction

2,123

Other

2

Total

2,360

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 →