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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 Polysomnograph With Electroencephalograph
510(k) Number K162627
Device Name EnsoSleep
Applicant
EnsoData, Inc.
111 N. Fairchild Street, Suite 240
Madison,  WI  53703
Applicant Contact Chris Fernandez
Correspondent
Michael Best & Friedrich, LLP
601 Pennsylvania Ave, NW Suite 700 South
Washington,  DC  20004
Correspondent Contact Seth A. Mailhot
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received09/20/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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