Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K872836 |
Device Name |
SPINOSCOPE |
Applicant |
DIAGNOSPINE FABRICATION, INC. |
1980 SHERBROOKE QUEST, |
SUITE 1100, MONTREAL QC., |
CANADA H3H 1E8,
CA
|
|
Applicant Contact |
GRACOVETSKY |
Correspondent |
DIAGNOSPINE FABRICATION, INC. |
1980 SHERBROOKE QUEST, |
SUITE 1100, MONTREAL QC., |
CANADA H3H 1E8,
CA
|
|
Correspondent Contact |
GRACOVETSKY |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 07/17/1987 |
Decision Date | 09/29/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|