The following data is part of a premarket notification filed by Cerebrotech Medical Systems with the FDA for Cerebrotech Cms-5000.
| Device ID | K171186 |
| 510k Number | K171186 |
| Device Name: | Cerebrotech CMS-5000 |
| Classification | Impedance Plethysmograph, Cranial |
| Applicant | Cerebrotech Medical Systems 1048 Serpentine Lane Suite 301 Pleasanton, CA 94566 |
| Contact | Dawnel Scott |
| Correspondent | Pamela M. Buckman Pamela M. Buckman, MSN 2800 Pleasant Hill Rd. #175 Pleasant Hill, CA 94523 |
| Product Code | QAF |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-12-08 |
| Summary: | summary |