510(k) K202062
- Device
- Wheezo WheezeRate Dector
- Applicant
- Respiri Limited
- 510(k) number
- K202062
- Product code
- PHZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-11
- Date received
- 2020-07-27
- Regulation
- 868.1900
- Classification name
- Abnormal Breath Sound Device
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Samaneh Sarraf
- Address
- Level 10, 446 Collins St. Melbourne AU 3000 3000
FDA Registration Numbers#
- 3021974922
- 3012678246
Source Documents#
Other 510(k) Records For Product Code PHZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | 2025-04-07 |
| K240555 | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | 2024-07-02 |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | 2023-12-13 |
| K221614 | TytoCare Lung Sounds Analyzer | Tyto Care , Ltd. | 2023-02-24 |
| K131285 | SONOSENTRY | Isonea, Ltd. | 2014-08-19 |
Legacy Summary#
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FDA Review#
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