The following data is part of a premarket notification filed by Neuro-fitness Llc with the FDA for Ces Ultra.
| Device ID | K062284 |
| 510k Number | K062284 |
| Device Name: | CES ULTRA |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | NEURO-FITNESS LLC P.O. BOX 1031 Snoqualmie, WA 98065 |
| Contact | Michael Stevens |
| Correspondent | Michael Stevens NEURO-FITNESS LLC P.O. BOX 1031 Snoqualmie, WA 98065 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2007-04-05 |
| Summary: | summary |