Digital Thermometer
K-Number: K161211 · 2016-08-29
ApplicantBiocare Asia Corporation , Ltd.
Decision Date2016-08-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Digital Thermometer is a medical device manufactured by Biocare Asia Corporation , Ltd.. It received FDA 510(k) clearance on 2016-08-29 under approval number K161211. 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 Digital Thermometer?
Digital Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-29. It is manufactured by Biocare Asia Corporation , Ltd.. The 510(k) number is K161211.
When was Digital Thermometer approved by the FDA?
Digital Thermometer received FDA 510(k) clearance on 2016-08-29, under approval number K161211.
What company makes Digital Thermometer?
Digital Thermometer is manufactured by Biocare Asia Corporation , Ltd..
What is the FDA product code for Digital Thermometer?
The FDA product code for Digital Thermometer 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.