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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 K071782
Device Name MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
Applicant
MICROMED S.P.A.
VIA GIOTTO 2
MOGLIANO VENETO (TV),  IT 31021
Applicant Contact MONICA CAMILLO
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact JAN VAN LOCHEM
Regulation Number882.1400
Classification Product Code
OLV  
Date Received07/02/2007
Decision Date 01/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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