FDA 510(k) Application Details - K010669

Device Classification Name Electroencephalograph

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510(K) Number K010669
Device Name Electroencephalograph
Applicant THURIS CORP.
110 GLENN WAY # 6
SAN CARLOS, CA 94070 US
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Contact GRACE BARTOO
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 03/06/2001
Decision Date 06/04/2001
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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