FDA 510(k) Application Details - K051228

Device Classification Name Plethysmograph, Impedance

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510(K) Number K051228
Device Name Plethysmograph, Impedance
Applicant CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO, CA 92121 US
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Contact DENNIS HEPP
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 05/13/2005
Decision Date 06/10/2005
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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