Substanially equivalent Device Classification NameAbnormal...

Substanially equivalent

Device Classification Name Abnormal Breath Sound Device 510(K) Number K202062 Device Name Wheezo WheezeRate Dector 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 Number 868.1900 Classification Product Code PHZ Date Received 07/27/2020 Decision Date 03/11/2021 Decision Substantially Equivalent (SESE) Regulation Medical Specialty Anesthesiology 510k Review Panel Anesthesiology Type Traditional Reviewed By Third Party No Combination Product No