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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
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