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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 K210034
Device Name EnsoSleep
Applicant
EnsoData, Inc.
111 S. Hamilton St. Suite 30
Madison,  WI  53703
Applicant Contact Sigrid Schoepel
Correspondent
EnsoData, Inc.
111 S. Hamilton St. Suite 30
Madison,  WI  53703
Correspondent Contact Sigrid Schoepel
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received01/06/2021
Decision Date 06/16/2021
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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