FDA 510(k) Application Details - K070985

Device Classification Name Plethysmograph, Impedance

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510(K) Number K070985
Device Name Plethysmograph, Impedance
Applicant OSYPKA MEDICAL, INC.
7855 IVANHOE AVE., SUITE 226
LA JOLLA, CA 92037 US
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Contact MARKUS OSYPKA
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 04/06/2007
Decision Date 02/01/2008
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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