Disposable Ear Thermometer Probe Cover— 510(k) K203431

Substantially Equivalent

Huaian Zhongxin Packing Material Co., Ltd.

FDA 510(k) clearance K203431 for Disposable Ear Thermometer Probe Cover, Substantially Equivalent on 2021-07-28. Applicant: Huaian Zhongxin Packing Material Co., Ltd..

Clearance details

Applicant: Huaian Zhongxin Packing Material Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-11-23
Decision date: 2021-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huaian, 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.