FDA product code NEQ: Device, Telemedicine, Robotic
NEQ is the FDA product code for device, telemedicine, robotic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under NEQ. The average 510(k) review took 168 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | Device, Telemedicine, Robotic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NEQ clearance
Top NEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Computer Motion, Inc. | 2 | 2001-12-10 |
Most recent NEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013804 | Computer Motion, Inc. | SOCRATES ROBOTIC TELEMONITORING SYSTEM | 2001-12-10 | 25 |
| K003661 | Computer Motion, Inc. | SOCRATES ROBOTIC TELEMONITORING SYSTEM | 2001-10-05 | 311 |
Recalls for NEQ devices
openFDA lists no recalls for product code NEQ.
Frequently asked questions
What is FDA product code NEQ?
NEQ is the FDA product code for device, telemedicine, robotic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is NEQ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEQ?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most NEQ clearances?
Computer Motion, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NEQ
- Run a recall and safety report across every NEQ manufacturer
- Watch product code NEQ 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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