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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K201054
Device Name SOMNOscreen plus
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Applicant Contact Stephanie Wolski
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Correspondent Contact Stephanie Wolski
Regulation Number882.1400
Classification Product Code
Subsequent Product Code
Date Received04/21/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No