The following data is part of a premarket notification filed by Cerebrotech Medical Systems, Inc. with the FDA for Visor System.
| Device ID | K182967 |
| 510k Number | K182967 |
| Device Name: | Visor System |
| Classification | Impedance Plethysmograph, Cranial |
| Applicant | Cerebrotech Medical Systems, Inc. 1048 Serpentine Lane Suite 301 Pleasanton, CA 94566 |
| Contact | Dawnel Scott |
| Correspondent | Dawnel Scott Cerebrotech Medical Systems, Inc. 1048 Serpentine Lane Suite 301 Pleasanton, CA 94566 |
| Product Code | QAF |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2018-11-23 |
| Summary: | summary |