Device Classification Name |
Device, Sleep Assessment
|
510(k) Number |
K040986 |
Device Name |
CADWELL LIMB MOVEMENT MODULE |
Applicant |
CADWELL LABORATORIES, INC. |
909 NORTH KELLOGG ST. |
KENNEWICK,
WA
99336
|
|
Applicant Contact |
CHRIS BOLKAN |
Correspondent |
CADWELL LABORATORIES, INC. |
909 NORTH KELLOGG ST. |
KENNEWICK,
WA
99336
|
|
Correspondent Contact |
CHRIS BOLKAN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/15/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|