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 |