Disposable Temperature Probe— 510(k) K193625

Substantially Equivalent

Shenzhen Changke Connect Electronics Co., Ltd.

FDA 510(k) clearance K193625 for Disposable Temperature Probe, Substantially Equivalent on 2020-07-24. Applicant: Shenzhen Changke Connect Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2019-12-26
Decision date: 2020-07-24
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.