Device Classification Name |
Device, Nerve Conduction Velocity Measurement
|
510(k) Number |
K932533 |
Device Name |
SMARTSCOPE |
Applicant |
INSIGHT MEDICAL CORP. |
173 FAIRVIEW AVENUE |
TORONTO, ONTARIO,
CA
M6P 3A6
|
|
Applicant Contact |
RICHARD MCMULLIN |
Correspondent |
INSIGHT MEDICAL CORP. |
173 FAIRVIEW AVENUE |
TORONTO, ONTARIO,
CA
M6P 3A6
|
|
Correspondent Contact |
RICHARD MCMULLIN |
Regulation Number | 882.1550
|
Classification Product Code |
|
Date Received | 05/26/1993 |
Decision Date | 03/31/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|