wheezo WheezeRate Detector
FDA 510(k) clearance K202062 · decided 2021-03-11
Clearance details
- K-number
- K202062
- Device name
- wheezo WheezeRate Detector
- Applicant
- Respiri Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-07-27
- Decision date
- 2021-03-11
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- PHZ
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Melbourne, AU
- Third-party review
- No
- Expedited review
- No
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| Tyto Insights for Wheeze Detection (with PCCP) (K252844) | Tyto Care , Ltd. | 2026-06-02 |
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| SONOSENTRY (K131285) | Isonea, Ltd. | 2014-08-19 |
Recalls involving this device
No recalls on record reference this clearance.