FDA 510(k) Application Details - K142503

Device Classification Name Plethysmograph, Impedance

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510(K) Number K142503
Device Name Plethysmograph, Impedance
Applicant INTERSECTION MEDICAL, INC.
1808 ASTON AVE STE 120
CARLSBAD, CA 92008-7364 US
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Contact WARREN CRAYCROFT
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 09/05/2014
Decision Date 06/05/2015
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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