Device Classification Name |
Device, Galvanic Skin Response Measurement
|
510(k) Number |
K100233 |
Device Name |
SUDOSCAN |
Applicant |
IMPETO MEDICAL |
4479 SHOREPOINTS WAY |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KYE CHEUNG |
Correspondent |
IMPETO MEDICAL |
4479 SHOREPOINTS WAY |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KYE CHEUNG |
Regulation Number | 882.1540
|
Classification Product Code |
|
Date Received | 01/26/2010 |
Decision Date | 06/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|