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mavericktrader4

27 Posts.

21/03/21

13:13

Post #: 51925831

Originally posted by mavericktrader4: ↑
Marjan Mikel informed attendees at the NWR virtual conference that he will have FDA approval before the end of this quarter as promised.The very concerning issue is the FDA decision was made 11/03/21 8 days prior and volume increased dramatically. Why a trading halt on the 19th after the presentation ????

510(k) Premarket Notification (fda.gov)

Under Listing Rule 3.1, an entity must disclose all information concerning it that it becomes aware of from any source and of any character, if a reasonable person would expect the information to have a material effect on the price or value of its securities.

https://youtu.be/-sc8um4H584

Device Classification NameAbnormal Breath Sound Device510(K) NumberK202062Device NameWheezo WheezeRate DectorApplicant
Respiri Limited
1 Level 10, 446 Collins Street
2 Melbourne, AU 3000
Applicant ContactSamaneh SarrafCorrespondent
Respiri Limited
1 Level 10, 446 Collins Street
2 Melbourne, AU 3000
Correspondent ContactSamaneh SarrafRegulation Number868.1900Classification Product Code
PHZ
Date Received07/27/2020Decision Date03/11/2021DecisionSubstantially Equivalent (SESE)Regulation Medical SpecialtyAnesthesiology510k Review PanelAnesthesiologyTypeTraditionalReviewed By Third PartyNoCombination ProductNo

Be great to hear a detailed response from Yenom23 Lucius vorenus Lucasq and all other Respiri investors on this issue
hope everyone is having a restful weekend
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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