K041908 is an FDA 510(k) clearance for the 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 (Minneapolis, US). The FDA issued a Cleared decision on February 25, 2005, 225 days after receiving the submission on July 15, 2004.
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 | K041908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2004 |
| Decision Date | February 25, 2005 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| 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 |