FDA 510(k) Application Details - K010164

Device Classification Name Plethysmograph, Impedance

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510(K) Number K010164
Device Name Plethysmograph, Impedance
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact KAREN WEBB
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 01/18/2001
Decision Date 04/09/2001
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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