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510(k) K243567

Tyto Insights for Rhonchi Detection by Tyto Care , Ltd. — Product Code PHZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 7, 2025
Date Received: November 18, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Abnormal Breath Sound Device
Device Class: Class II
Regulation Number: 868.1900
Review Panel: AN
Submission Type

The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.

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K190242 — Tyto Thermometer (March 27, 2019)
K181612 — Tyto Stethoscope (OTC) (December 17, 2018)
K160401 — Tyto Stethoscope (October 19, 2016)