iHealth Clinical Digital Thermometer
K-Number: K202791 · 2021-01-05
ApplicantAndon Health Co, Ltd.
Decision Date2021-01-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
iHealth Clinical Digital Thermometer is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2021-01-05 under approval number K202791. 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 iHealth Clinical Digital Thermometer?
iHealth Clinical Digital Thermometer is a medical device that received FDA 510(k) clearance on 2021-01-05. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K202791.
When was iHealth Clinical Digital Thermometer approved by the FDA?
iHealth Clinical Digital Thermometer received FDA 510(k) clearance on 2021-01-05, under approval number K202791.
What company makes iHealth Clinical Digital Thermometer?
iHealth Clinical Digital Thermometer is manufactured by Andon Health Co, Ltd..
What is the FDA product code for iHealth Clinical Digital Thermometer?
The FDA product code for iHealth Clinical Digital Thermometer is FLL.
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Other Devices by Andon Health Co, Ltd.
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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.