Decision Date2019-07-26
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Infrared Ear/Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190873. 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 Ear/Forehead Thermometer?
Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K190873.
When did Infrared Ear/Forehead Thermometer receive FDA 510(k) clearance?
Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190873.
Who is the listed applicant for Infrared Ear/Forehead Thermometer?
The FDA 510(k) record lists Joytech Healthcare Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infrared Ear/Forehead Thermometer?
The FDA product code for Infrared Ear/Forehead Thermometer is FLL.
Other records listing Joytech Healthcare Co. , Ltd. as applicant
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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.