Tyto Insights for Rhonchi Detection— 510(k) K243567

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K243567 for Tyto Insights for Rhonchi Detection, Substantially Equivalent on 2025-04-07. Applicant: Tyto Care , Ltd..

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code PHZ
Advisory panel: Anesthesiology
Date received: 2024-11-18
Decision date: 2025-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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