510(k) K252844
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2026
- Date Received
- September 8, 2025
- 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
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.