Tyto Insights for Wheeze Detection (with PCCP)— 510(k) K252844

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K252844 for Tyto Insights for Wheeze Detection (with PCCP), Substantially Equivalent on 2026-06-02. Applicant: Tyto Care , Ltd..

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code PHZ
Advisory panel: Anesthesiology
Date received: 2025-09-08
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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