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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for full-montage electroencephalograph
510(k) Number K140552
FOIA Releasable 510(k) K140552
Device Name CADWELL SPIKE AND SEIZURE DETECTOR
Applicant
CADWELL
909 N. KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact JINESH JAIN
Correspondent
CADWELL
909 N. KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact JINESH JAIN
Regulation Number882.1400
Classification Product Code
OMB  
Date Received03/04/2014
Decision Date 07/23/2014
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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