QBE — Cranial Sound Monitor Class II
FDA product code QBE covers "Cranial Sound Monitor", a Class II medical device regulated under 21 CFR 870.1875. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QBE
- Device Class
- Class II
- Regulation Number
- 870.1875
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172892 | headsense medical | Neuro Assessment System NAS-1000 | March 8, 2018 |