Withings Thermo (Model SCT01)
K-Number: K160544 · 2016-06-17
ApplicantWithings
Decision Date2016-06-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Withings Thermo (Model SCT01) is a medical device manufactured by Withings. It received FDA 510(k) clearance on 2016-06-17 under approval number K160544. 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 Withings Thermo (Model SCT01)?
Withings Thermo (Model SCT01) is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Withings. The 510(k) number is K160544.
When was Withings Thermo (Model SCT01) approved by the FDA?
Withings Thermo (Model SCT01) received FDA 510(k) clearance on 2016-06-17, under approval number K160544.
What company makes Withings Thermo (Model SCT01)?
Withings Thermo (Model SCT01) is manufactured by Withings.
What is the FDA product code for Withings Thermo (Model SCT01)?
The FDA product code for Withings Thermo (Model SCT01) 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.