FDA 510(k) Application Details - K011439

Device Classification Name Plethysmograph, Impedance

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510(K) Number K011439
Device Name Plethysmograph, Impedance
Applicant CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO, CA 92121 US
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Contact BRIAN PARK
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 05/10/2001
Decision Date 11/02/2001
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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