K052357 is an FDA 510(k) clearance for the PATHWAY - ATS/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 January 19, 2006, 143 days after receiving the submission on August 29, 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 | K052357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2005 |
| Decision Date | January 19, 2006 |
| Days to Decision | 143 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 |