Device Classification Name |
Cranial Motion Measurement Device
|
510(k) Number |
K170926 |
Device Name |
BrainPulse 1100 |
Applicant |
Jan Medical, Inc. |
110 Pioneer Way, Suite L |
Mountain View,
CA
94041
|
|
Applicant Contact |
Prabhu Raghavan |
Correspondent |
Jan Medical, Inc. |
110 Pioneer Way, Suite L |
Mountain View,
CA
94041
|
|
Correspondent Contact |
Prabhu Raghavan |
Regulation Number | 882.1630
|
Classification Product Code |
|
Date Received | 03/29/2017 |
Decision Date | 04/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|