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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K072382
Device Name MODEL I-2000 MONITOR
Applicant
Infinite Biomedical Technologies
3600 Clipper Mill Rd.
Suite 410
Baltimore,  MD  21211
Applicant Contact MANAN HATHI
Correspondent
Infinite Biomedical Technologies
3600 Clipper Mill Rd.
Suite 410
Baltimore,  MD  21211
Correspondent Contact MANAN HATHI
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received08/24/2007
Decision Date 02/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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