FDA product code QBE: Cranial Sound Monitor
QBE is the FDA product code for cranial sound monitor. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QBE. The average 510(k) review took 167 days (median 167).
Definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Sound Monitor |
| Device class | Class II |
| Regulation | 21 CFR 870.1875 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QBE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 167 |
Compare with all 510(k) review times · Search every QBE clearance
Top QBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Headsense Medical, Inc. | 1 | 2018-03-08 |
Most recent QBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172892 | Headsense Medical, Inc. | Neuro Assessment System NAS-1000 | 2018-03-08 | 167 |
Recalls for QBE devices
openFDA lists no recalls for product code QBE.
Frequently asked questions
What is FDA product code QBE?
QBE is the FDA product code for cranial sound monitor. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Neurology panel.
What device class is QBE?
Class II, regulation 21 CFR 870.1875. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBE?
Across 1 cleared submissions the average was 167 days from receipt to decision (median 167).
Which companies have the most QBE clearances?
Headsense Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBE
- Run a recall and safety report across every QBE manufacturer
- Watch product code QBE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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