Tyto Insights for Wheeze Detection— 510(k) K232237

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K232237 for Tyto Insights for Wheeze Detection, Substantially Equivalent on 2023-12-13. Applicant: Tyto Care , Ltd..

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code PHZ
Advisory panel: Anesthesiology
Date received: 2023-07-28
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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