Device Classification Name |
Device, Sleep Assessment
|
510(k) Number |
K181077 |
Device Name |
ActiGraph CentrePoint Insight Watch |
Applicant |
ActiGraph |
49 E Chase St |
Pensacola,
FL
32502
|
|
Applicant Contact |
Brian Bell |
Correspondent |
ActiGraph |
49 E Chase St |
Pensacola,
FL
32502
|
|
Correspondent Contact |
Brian Bell |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 04/24/2018 |
Decision Date | 05/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|