The following data is part of a premarket notification filed by Medoc Ltd. Advanced Medical Systems with the FDA for Pathway - Ats/cheps.
| Device ID | K052357 |
| 510k Number | K052357 |
| Device Name: | PATHWAY - ATS/CHEPS |
| Classification | Evoked Potential Stimulator, Thermal |
| Applicant | MEDOC LTD. ADVANCED MEDICAL SYSTEMS 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub MEDOC LTD. ADVANCED MEDICAL SYSTEMS 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | NTU |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2006-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290103039806 | K052357 | 000 |