Device Classification Name |
Goniometer, Ac-Powered
|
510(k) Number |
K954647 |
Device Name |
INCLINOMETER |
Applicant |
J-TECH, INC. |
50 WEST CANYON RD. |
ALPINE,
UT
84004
|
|
Applicant Contact |
J. TRACY LIVINGSTON |
Correspondent |
J-TECH, INC. |
50 WEST CANYON RD. |
ALPINE,
UT
84004
|
|
Correspondent Contact |
J. TRACY LIVINGSTON |
Regulation Number | 888.1500
|
Classification Product Code |
|
Date Received | 10/10/1995 |
Decision Date | 10/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|