FDA 510(k) Application Details - K992410

Device Classification Name Electroencephalograph

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510(K) Number K992410
Device Name Electroencephalograph
Applicant INDIVIDUAL MONITORING SYSTEMS, INC.
1055 TAYLOR AVE., SUITE 300
BALTIMORE, MD 21286-8334 US
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Contact DAVID T KRAUSMAN
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 07/20/1999
Decision Date 10/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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