The following data is part of a premarket notification filed by Chatten Associates, Inc. with the FDA for S12x With Esax Option.
| Device ID | K082629 |
| 510k Number | K082629 |
| Device Name: | S12X WITH ESAX OPTION |
| Classification | Electrode, Cortical |
| Applicant | CHATTEN ASSOCIATES, INC. 1094 NEW DEHAVEN AVE SUITE 200 West Conshohocken, PA 19428 |
| Contact | John B Chatten |
| Correspondent | John B Chatten CHATTEN ASSOCIATES, INC. 1094 NEW DEHAVEN AVE SUITE 200 West Conshohocken, PA 19428 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-07-01 |
| Summary: | summary |