DIGITAL FOREHEAD THERMOMETER— 510(k) K103617

Substantially Equivalent

K-Jump Health Co., Ltd.

FDA 510(k) clearance K103617 for DIGITAL FOREHEAD THERMOMETER, Substantially Equivalent on 2011-04-04. Applicant: K-Jump Health Co., Ltd..

Clearance details

Applicant: K-Jump Health Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-12-10
Decision date: 2011-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei Hsien, TW

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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.