Device Classification Name |
device, sleep assessment
|
510(k) Number |
K132764 |
Device Name |
MOTION WATCH AND PRO-DIARY |
Applicant |
CAMNTECH, LTD |
UPPER PENDRILL COURT |
PAPWORTH EVERARD, CAMBRIDGESHIRE,
GB
CB233UY
|
|
Applicant Contact |
HOWARD SMITH |
Correspondent |
CAMNTECH, LTD |
UPPER PENDRILL COURT |
PAPWORTH EVERARD, CAMBRIDGESHIRE,
GB
CB233UY
|
|
Correspondent Contact |
HOWARD SMITH |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 09/04/2013 |
Decision Date | 01/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|