Tyto Insights for Rhonchi Detection
K-Number: K243567 · 2025-04-07
ApplicantTyto Care , Ltd.
Decision Date2025-04-07
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Tyto Insights for Rhonchi Detection is a medical device manufactured by Tyto Care , Ltd.. It received FDA 510(k) clearance on 2025-04-07 under approval number K243567. 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 Rhonchi Detection?
Tyto Insights for Rhonchi Detection is a medical device that received FDA 510(k) clearance on 2025-04-07. It is manufactured by Tyto Care , Ltd.. The 510(k) number is K243567.
When was Tyto Insights for Rhonchi Detection approved by the FDA?
Tyto Insights for Rhonchi Detection received FDA 510(k) clearance on 2025-04-07, under approval number K243567.
What company makes Tyto Insights for Rhonchi Detection?
Tyto Insights for Rhonchi Detection is manufactured by Tyto Care , Ltd..
What is the FDA product code for Tyto Insights for Rhonchi Detection?
The FDA product code for Tyto Insights for Rhonchi Detection is PHZ.
Related PubMed Literature
Other Devices by Tyto Care , 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.