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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number882.1540
Classification Product Code
GZO  
Date Received01/26/2010
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
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