FDA product code QEM: Cerebral Oximeter
QEM is the FDA product code for cerebral oximeter. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QEM. The average 510(k) review took 128 days (median 128).
Definition
Oximeter to measure cerebral tissue saturation
Classification
| Field | Value |
|---|---|
| Device name | Cerebral Oximeter |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QEM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 128 |
Compare with all 510(k) review times · Search every QEM clearance
Top QEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mespere Lifesciences, Inc. | 1 | 2018-12-26 |
Most recent QEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182242 | Mespere Lifesciences, Inc. | VO200 NeurOs Cerebral Oximetry System | 2018-12-26 | 128 |
Recalls for QEM devices
openFDA lists no recalls for product code QEM.
Frequently asked questions
What is FDA product code QEM?
QEM is the FDA product code for cerebral oximeter. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Neurology panel.
What device class is QEM?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEM?
Across 1 cleared submissions the average was 128 days from receipt to decision (median 128).
Which companies have the most QEM clearances?
Mespere Lifesciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEM
- Run a recall and safety report across every QEM manufacturer
- Watch product code QEM 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times