FDA 510(k) Application Details - K032491

Device Classification Name Plethysmograph, Impedance

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510(K) Number K032491
Device Name Plethysmograph, Impedance
Applicant IMAGYN MEDICAL TECHNOLOGIES, INC.
1 PARK PLAZA, SUITE 1100
IRVINE, CA 92614 US
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Contact JULIE POWELL
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 08/12/2003
Decision Date 09/04/2003
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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