Infrared Thermometer Model Number RN-50A,RN-50B— 510(k) K200578

Substantially Equivalent

Ningbo Ranor Medical Science & Technology Co., Ltd.

FDA 510(k) clearance K200578 for Infrared Thermometer Model Number RN-50A,RN-50B, Substantially Equivalent on 2020-07-16. Applicant: Ningbo Ranor Medical Science & Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Ningbo Ranor Medical Science & Technology Co., Ltd.
Product code
Code FLL
Device class
Class 2
Regulation
21 CFR 880.2910
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ningbo, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . 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.