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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K101386
FOIA Releasable 510(k) K101386
Device Name VIGILANT EEG MONITOR MODEL VIGILANT 2.0
Applicant
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
3600 CLIPPER MILL ROAD
SUITE 410
BALTIMORE,  MD  21211
Applicant Contact MANAN HATHI
Correspondent
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
3600 CLIPPER MILL ROAD
SUITE 410
BALTIMORE,  MD  21211
Correspondent Contact MANAN HATHI
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received05/18/2010
Decision Date 07/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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