Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)— 510(k) K220657

Substantially Equivalent

Zhejiang Rongsheng Industrial Co., Ltd.

FDA 510(k) clearance K220657 for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001), Substantially Equivalent on 2023-02-10. Applicant: Zhejiang Rongsheng Industrial Co., Ltd..

Clearance details

Applicant: Zhejiang Rongsheng Industrial Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2022-03-07
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiaoshun Town, Jinhua, 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.