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FDA 510(k) Applications for Medical Device Product Code "PHZ"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K131285
ISONEA LTD
SONOSENTRY
08/19/2014
K202062
Respiri Limited
wheezo WheezeRate Detector
03/11/2021
K240555
Tyto Care Ltd.
Tyto Insights for Crackles Detection
07/02/2024
K243567
Tyto Care Ltd.
Tyto Insights for Rhonchi Detection
04/07/2025
K232237
Tyto Care Ltd.
Tyto Insights for Wheeze Detection
12/13/2023
K221614
Tyto Care Ltd.
TytoCare Lung Sounds Analyzer
02/24/2023
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