QBE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cranial Sound Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Medical specialty
- Cardiovascular
- FDA definition
- To non-invasively detect, monitor, record and display acoustic signals in the brain.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Neuro Assessment System NAS-1000 (K172892) | Headsense Medical, Inc. | 2018-03-08 | + Add |
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Every clearance here is in the API, with alerts when new ones post.