Device Classification Name |
Goniometer, Ac-Powered
|
510(k) Number |
K940812 |
Device Name |
INSIGHT ELECTRONIC ALIGNMENT INDICATOR |
Applicant |
ANDRONIC DEVICES, LTD. |
SUITE 140 |
13120 VANIER PLACE |
RICHMOND, B.C. CANADA V6V 2J2,
CA
V6V 2J2
|
|
Applicant Contact |
ROBERT MACNEIL |
Correspondent |
ANDRONIC DEVICES, LTD. |
SUITE 140 |
13120 VANIER PLACE |
RICHMOND, B.C. CANADA V6V 2J2,
CA
V6V 2J2
|
|
Correspondent Contact |
ROBERT MACNEIL |
Regulation Number | 888.1500
|
Classification Product Code |
|
Date Received | 02/22/1994 |
Decision Date | 11/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|