Wheezo WheezeRate Dector

Abnormal Breath Sound Device

Respiri Limited

The following data is part of a premarket notification filed by Respiri Limited with the FDA for Wheezo Wheezerate Dector.

Pre-market Notification Details

Device IDK202062
510k NumberK202062
Device Name:Wheezo WheezeRate Dector
ClassificationAbnormal Breath Sound Device
Applicant Respiri Limited Level 10, 446 Collins Street Melbourne,  AU 3000
ContactSamaneh Sarraf
CorrespondentSamaneh Sarraf
Respiri Limited Level 10, 446 Collins Street Melbourne,  AU 3000
Product CodePHZ  
CFR Regulation Number868.1900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2021-03-11

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