Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
K-Number: K220657 · 2023-02-10
Decision Date2023-02-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is a medical device manufactured by Zhejiang Rongsheng Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under approval number K220657. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Zhejiang Rongsheng Industrial Co., Ltd.. The 510(k) number is K220657.
When was Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) approved by the FDA?
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) received FDA 510(k) clearance on 2023-02-10, under approval number K220657.
What company makes Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is manufactured by Zhejiang Rongsheng Industrial Co., Ltd..
What is the FDA product code for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?
The FDA product code for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is FLL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.