NTU · Evoked Potential Stimulator, Thermal
Neurology · 21 CFR 882.1870 · Class 2
Overview
| Product Code | NTU |
|---|---|
| Device Name | Evoked Potential Stimulator, Thermal |
| Regulation | 21 CFR 882.1870 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
Classification Rationale
Class II (performance standards).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052357 | PATHWAY - ATS/CHEPS | Medoc Ltd. Advanced Medical Systems | Jan 19, 2006 | SESE |
| K051448 | MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) | Medoc Ltd. Advanced Medical Systems | Jun 29, 2005 | SESE |
| K041908 | CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) | Medoc Ltd. Advanced Medical Systems | Feb 25, 2005 | SESE |
Top Applicants
- Medoc Ltd. Advanced Medical Systems — 3 clearances
