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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 K101830
Device Name ZMACHINE, MODEL DT-100
Applicant
CONSOLIDATED RESEARCH OF RICHMOND, INC
26250 EUCLID AVE
SUITE 024
EUCLID,  OH  44132
Applicant Contact RICHARD KAPLAN
Correspondent
CONSOLIDATED RESEARCH OF RICHMOND, INC
26250 EUCLID AVE
SUITE 024
EUCLID,  OH  44132
Correspondent Contact RICHARD KAPLAN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
OMC  
Date Received07/01/2010
Decision Date 03/31/2011
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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