FDA 510(k) Application Details - K020335

Device Classification Name Reduced- Montage Standard Electroencephalograph

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510(K) Number K020335
Device Name Reduced- Montage Standard Electroencephalograph
Applicant OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE, WA 98108 US
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Contact EDWARD B (TED) WEILER
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Regulation Number 882.1400

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Classification Product Code OMC
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Date Received 02/01/2002
Decision Date 06/18/2002
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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