Probe Covers for Thermometers— 510(k) K180714

Substantially Equivalent

K-Jump Health Co., Ltd.

FDA 510(k) clearance K180714 for Probe Covers for Thermometers, Substantially Equivalent on 2018-09-24. Applicant: K-Jump Health Co., Ltd..

Clearance details

Applicant: K-Jump Health Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2018-03-19
Decision date: 2018-09-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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.