FDA 510(k) Application Details - K001112

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K001112
Device Name Display, Cathode-Ray Tube, Medical
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact DAVID WAHLIG
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 04/06/2000
Decision Date 06/14/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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