The following data is part of a premarket notification filed by Jan Medical, Inc. with the FDA for Brainpulse 1100.
| Device ID | K170926 |
| 510k Number | K170926 |
| Device Name: | BrainPulse 1100 |
| Classification | Cranial Motion Measurement Device |
| Applicant | Jan Medical, Inc. 110 Pioneer Way, Suite L Mountain View, CA 94041 |
| Contact | Prabhu Raghavan |
| Correspondent | Prabhu Raghavan Jan Medical, Inc. 110 Pioneer Way, Suite L Mountain View, CA 94041 |
| Product Code | POP |
| CFR Regulation Number | 882.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-29 |
| Decision Date | 2017-04-28 |
| Summary: | summary |