Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)— 510(k) K243000

Substantially Equivalent

Shenzhen Medke Technology Co., Ltd.

FDA 510(k) clearance K243000 for Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106), Substantially Equivalent on 2025-06-20. Applicant: Shenzhen Medke Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Medke Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2024-09-26
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.