Decision Date2020-10-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200802. 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 Infrared Thermometer?
Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K200802.
When did Infrared Thermometer receive FDA 510(k) clearance?
Infrared Thermometer received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200802.
Who is the listed applicant for Infrared Thermometer?
The FDA 510(k) record lists Shenzhen Urion Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infrared Thermometer?
The FDA product code for Infrared Thermometer is FLL.
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Other records listing Shenzhen Urion Technology Co., Ltd. as applicant
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Related Devices (Code: 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.