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FDA 510(k)

Tyto Thermometer

K-Number: K190242 · 2019-03-27

Decision Date2019-03-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tyto Thermometer is a medical device manufactured by Tyto Care , Ltd.. It received FDA 510(k) clearance on 2019-03-27 under approval number K190242. 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 Tyto Thermometer?

Tyto Thermometer is a medical device that received FDA 510(k) clearance on 2019-03-27. It is manufactured by Tyto Care , Ltd.. The 510(k) number is K190242.

When was Tyto Thermometer approved by the FDA?

Tyto Thermometer received FDA 510(k) clearance on 2019-03-27, under approval number K190242.

What company makes Tyto Thermometer?

Tyto Thermometer is manufactured by Tyto Care , Ltd..

What is the FDA product code for Tyto Thermometer?

The FDA product code for Tyto Thermometer is FLL.

Other Devices by Tyto Care , Ltd.

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Related Devices (Code: FLL)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.