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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for full-montage electroencephalograph
510(k) Number K141883
Device Name CLINISCANSM EEG
Applicant
PICOFEMTO LLC
131 W. 35TH STREET, 8TH FLOOR
NEW YORK,  NY  10001
Applicant Contact SRIKANT KRISHNA
Correspondent
PICOFEMTO LLC
228 East 45th St., 2nd Floor
NEW YORK,  NY  10001
Correspondent Contact SRIKANT KRISHNA
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Code
OLT  
Date Received07/11/2014
Decision Date 05/15/2015
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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