FDA 510(k) Application Details - K050098

Device Classification Name Nystagmograph

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510(K) Number K050098
Device Name Nystagmograph
Applicant DDAT(UK) LTD
91 CLIDDESDEN ROAD
BASINGSTOKE, HAMPSHIRE RG21 3EY GB
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Contact PETER LIOYD
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Regulation Number 882.1460

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Classification Product Code GWN
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Date Received 01/18/2005
Decision Date 05/23/2005
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 Y
Expedited Review



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