MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM— 510(k) K061741

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K061741 for MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM, Substantially Equivalent on 2006-09-15. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2006-06-20
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

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Adverse events under product code DQK

product code DQK

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 →

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