Tyto Insights for Wheeze Detection
K-Number: K232237 · 2023-12-13
ApplicantTyto Care , Ltd.
Decision Date2023-12-13
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Tyto Insights for Wheeze Detection is a medical device manufactured by Tyto Care , Ltd.. It received FDA 510(k) clearance on 2023-12-13 under approval number K232237. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tyto Insights for Wheeze Detection?
Tyto Insights for Wheeze Detection is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Tyto Care , Ltd.. The 510(k) number is K232237.
When was Tyto Insights for Wheeze Detection approved by the FDA?
Tyto Insights for Wheeze Detection received FDA 510(k) clearance on 2023-12-13, under approval number K232237.
What company makes Tyto Insights for Wheeze Detection?
Tyto Insights for Wheeze Detection is manufactured by Tyto Care , Ltd..
What is the FDA product code for Tyto Insights for Wheeze Detection?
The FDA product code for Tyto Insights for Wheeze Detection is PHZ.
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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.