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FDA 510(k)

Tyto Insights for Crackles Detection

K-Number: K240555 · 2024-07-02

Decision Date2024-07-02
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Tyto Insights for Crackles Detection is a medical device manufactured by Tyto Care , Ltd.. It received FDA 510(k) clearance on 2024-07-02 under approval number K240555. 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 Crackles Detection?

Tyto Insights for Crackles Detection is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Tyto Care , Ltd.. The 510(k) number is K240555.

When was Tyto Insights for Crackles Detection approved by the FDA?

Tyto Insights for Crackles Detection received FDA 510(k) clearance on 2024-07-02, under approval number K240555.

What company makes Tyto Insights for Crackles Detection?

Tyto Insights for Crackles Detection is manufactured by Tyto Care , Ltd..

What is the FDA product code for Tyto Insights for Crackles Detection?

The FDA product code for Tyto Insights for Crackles Detection is PHZ.

Other Devices by Tyto Care , Ltd.

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Related Devices (Code: PHZ)

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.