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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K080217
Device Name COMPONENT NEUROMONITORING SYSTEM
Applicant
Moberg Research, Inc.
224 S. Maple Way
Ambler,  PA  19002
Applicant Contact Damon Lees
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
GWQ   MHX   MUD   OLT   ORT  
Date Received01/29/2008
Decision Date 11/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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