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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 K172986
Device Name Zmachine Synergy
Applicant
Consolidated Research of Richmond, Inc. dba General Sleep Co
26250 Euclid Avenue, Suite 709
Cleveland,  OH  44132
Applicant Contact Richard Kaplan
Correspondent
Consolidated Research of Richmond, Inc. dba General Sleep Co
26250 Euclid Avenue, Suite 709
Cleveland,  OH  44132
Correspondent Contact Richard Kaplan
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
MNR   OMC  
Date Received09/27/2017
Decision Date 12/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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