The following data is part of a premarket notification filed by Respiri Limited with the FDA for Wheezo Wheezerate Dector.
| Device ID | K202062 |
| 510k Number | K202062 |
| Device Name: | Wheezo WheezeRate Dector |
| Classification | Abnormal Breath Sound Device |
| Applicant | Respiri Limited Level 10, 446 Collins Street Melbourne, AU 3000 |
| Contact | Samaneh Sarraf |
| Correspondent | Samaneh Sarraf Respiri Limited Level 10, 446 Collins Street Melbourne, AU 3000 |
| Product Code | PHZ |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2021-03-11 |