wheezo WheezeRate Detector— 510(k) K202062
Substantially EquivalentRespiri Limited
FDA 510(k) clearance K202062 for wheezo WheezeRate Detector, Substantially Equivalent on 2021-03-11. Applicant: Respiri Limited. Device class: 2.
Clearance details
- Applicant
- Respiri Limited
- Product code
- Code PHZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.1900
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melbourne, AU
Recent devices under product code PHZ
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