510(k) K200471— Infrared Thermometer Model Number RN-60A,RN-60B

Substantially Equivalent

Ningbo Ranor Medical Science & Technology Co., Ltd.

Clearance details

Applicant: Ningbo Ranor Medical Science & Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-02-26
Decision date: 2020-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

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.