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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 K010997
Device Name PAM-RL
Applicant
Individual Monitoring Systems, Inc.
1055 Taylor Ave., Suite 300
Baltimore,  MD  21286 -8334
Applicant Contact DAVID T KRAUSMAN
Correspondent
Individual Monitoring Systems, Inc.
1055 Taylor Ave., Suite 300
Baltimore,  MD  21286 -8334
Correspondent Contact DAVID T KRAUSMAN
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received04/03/2001
Decision Date 10/15/2001
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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