THERMOFLASH LX-26— 510(k) K080759

Substantially Equivalent

Jxb Co. Ltd Guangzhou (China)

FDA 510(k) clearance K080759 for THERMOFLASH LX-26, Substantially Equivalent on 2008-05-12. Applicant: Jxb Co. Ltd Guangzhou (China).

Clearance details

Applicant: Jxb Co. Ltd Guangzhou (China)
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2008-03-18
Decision date: 2008-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Panuy, Guangzhou, CN

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.