The following data is part of a premarket notification filed by Innovative Neurological Devices Llc with the FDA for Cervella.
| Device ID | K182311 |
| 510k Number | K182311 |
| Device Name: | Cervella |
| Classification | Stimulator, Cranial Electrotherapy |
| Applicant | Innovative Neurological Devices LLC 13295 Illinois St, Suite 312 Carmel, IN 46032 |
| Contact | Bart Waclawik |
| Correspondent | Bart Waclawik Innovative Neurological Devices LLC 13295 Illinois St, Suite 312 Carmel, IN 46032 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2019-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001493306 | K182311 | 000 |