TytoCare Lung Sounds Analyzer
K-Number: K221614 · 2023-02-24
ApplicantTyto Care , Ltd.
Decision Date2023-02-24
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TytoCare Lung Sounds Analyzer is a medical device manufactured by Tyto Care , Ltd.. It received FDA 510(k) clearance on 2023-02-24 under approval number K221614. 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 TytoCare Lung Sounds Analyzer?
TytoCare Lung Sounds Analyzer is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Tyto Care , Ltd.. The 510(k) number is K221614.
When was TytoCare Lung Sounds Analyzer approved by the FDA?
TytoCare Lung Sounds Analyzer received FDA 510(k) clearance on 2023-02-24, under approval number K221614.
What company makes TytoCare Lung Sounds Analyzer?
TytoCare Lung Sounds Analyzer is manufactured by Tyto Care , Ltd..
What is the FDA product code for TytoCare Lung Sounds Analyzer?
The FDA product code for TytoCare Lung Sounds Analyzer is PHZ.
Other Devices by Tyto Care , Ltd.
Related Devices (Code: PHZ)
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.