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FDA 510(k)

Tyto Insights for Wheeze Detection (with PCCP)

K-Number: K252844 · 2026-06-02

Decision Date2026-06-02
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Tyto Insights for Wheeze Detection (with PCCP) is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K252844. 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 (with PCCP)?

Tyto Insights for Wheeze Detection (with PCCP) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K252844.

When did Tyto Insights for Wheeze Detection (with PCCP) receive FDA 510(k) clearance?

Tyto Insights for Wheeze Detection (with PCCP) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K252844.

Who is the listed applicant for Tyto Insights for Wheeze Detection (with PCCP)?

The FDA 510(k) record lists Tyto Care , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyto Insights for Wheeze Detection (with PCCP)?

The FDA product code for Tyto Insights for Wheeze Detection (with PCCP) is PHZ.

Other records listing Tyto Care , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: PHZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.