DISPOSABLE THERMOMETER COVERS AND SHEATHS— 510(k) K112289

Substantially Equivalent

Kang ZE Industrial Co. Limited

FDA 510(k) clearance K112289 for DISPOSABLE THERMOMETER COVERS AND SHEATHS, Substantially Equivalent on 2011-12-16. Applicant: Kang ZE Industrial Co. Limited.

Clearance details

Applicant: Kang ZE Industrial Co. Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-08-09
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Songjiang Area, Shanghai, 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.