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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 K141872
Device Name SUDOSCAN
Applicant
IMPETO MEDICAL INC
400 n. washington st., ste 100
medical devices division
alexandria,  VA  22314
Applicant Contact calley herzog
Correspondent
IMPETO MEDICAL INC
400 n. washington st., ste 100
medical devices division
alexandria,  VA  22314
Correspondent Contact calley herzog
Regulation Number882.1540
Classification Product Code
GZO  
Date Received07/11/2014
Decision Date 11/21/2014
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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