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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abnormal breath sound device
510(k) Number K202062
Device Name wheezo WheezeRate Detector
Applicant
Respiri Limited
Level 10, 446 Collins Street
Melbourne,  AU 3000
Applicant Contact Samaneh Sarraf
Correspondent
Respiri Limited
Level 10, 446 Collins Street
Melbourne,  AU 3000
Correspondent Contact Samaneh Sarraf
Regulation Number868.1900
Classification Product Code
PHZ  
Date Received07/27/2020
Decision Date 03/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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