K051448 is an FDA 510(k) clearance for the MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS). This device is classified as a Evoked Potential Stimulator, Thermal (Class II - Special Controls, product code NTU).
Submitted by Medoc Ltd. Advanced Medical Systems (Somerset, US). The FDA issued a Cleared decision on June 29, 2005, 27 days after receiving the submission on June 2, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870. Intended To Evaluate The Functionality Of Human Pain Reception And Transmission Of Sensory Pathways.
| 510(k) Number | K051448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2005 |
| Decision Date | June 29, 2005 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NTU — Evoked Potential Stimulator, Thermal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |
| Definition | Intended To Evaluate The Functionality Of Human Pain Reception And Transmission Of Sensory Pathways |