Fact : decision was made 11/03/21 trading halt :19/03/21Device Classification NameAbnormal Breath Sound Device510(K) NumberK202062Device NameWheezo WheezeRate DectorApplicantRespiri LimitedLevel 10, 446 Collins StreetMelbourne, AU 3000Applicant ContactSamaneh SarrafCorrespondentRespiri LimitedLevel 10, 446 Collins StreetMelbourne, AU 3000Correspondent ContactSamaneh SarrafRegulation Number868.1900Classification Product CodePHZ Date Received07/27/2020Decision Date03/11/2021DecisionSubstantially Equivalent (SESE)Regulation Medical SpecialtyAnesthesiology 510k Review PanelAnesthesiologyTypeTraditionalReviewed By Third PartyNoCombination ProductNo
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
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No. | Vol. | Price($) |
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3 | 626327 | 0.053 |
1 | 311458 | 0.048 |
1 | 12000 | 0.047 |
4 | 1172112 | 0.045 |
Price($) | Vol. | No. |
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0.055 | 119047 | 1 |
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