Device Classification Name |
dynamometer, ac-powered
|
510(k) Number |
K914436 |
Device Name |
CLINICAL HANDMASTER SYSTEM OR CHMS |
Applicant |
EXOS MEDICAL PRODUCTS |
8 BLANCHARD RD. |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
BETH A MARCUS |
Correspondent |
EXOS MEDICAL PRODUCTS |
8 BLANCHARD RD. |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
BETH A MARCUS |
Regulation Number | 888.1240
|
Classification Product Code |
|
Date Received | 10/04/1991 |
Decision Date | 01/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|