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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 K142825
Device Name Zmachine
Applicant
CONSOLIDATED RESEARCH OF RICHMOND, INC
26250 EUCLID AVE
SUITE 709
EUCLID,  OH  44132
Applicant Contact Richard Kaplan
Correspondent
CONSOLIDATED RESEARCH OF RICHMOND, INC
26250 EUCLID AVE
SUITE 709
EUCLID,  OH  44132
Correspondent Contact Richard Kaplan
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Codes
OLV   OMC  
Date Received09/30/2014
Decision Date 01/20/2015
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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