510(k) K202062
K202062 is an FDA 510(k) premarket notification submitted by Respiri Limited for the device "wheezo WheezeRate Detector". The FDA issued a decision of Substantially Equivalent on Mar 11, 2021. The device falls under product code PHZ (Abnormal Breath Sound Device), a Class II device regulated under 21 CFR 868.1900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 2021
- Date Received
- Jul 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abnormal Breath Sound Device
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type
- 510(k)
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.