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FDA 510(k) Application Details - K001081
Device Classification Name
Plethysmograph, Impedance
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510(K) Number
K001081
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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More FDA Info for this Product Code
Date Received
04/04/2000
Decision Date
06/30/2000
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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