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FDA 510(k) Application Details - K972320
Device Classification Name
Plethysmograph, Impedance
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510(K) Number
K972320
Device Name
Plethysmograph, Impedance
Applicant
CARDIODYNAMICS INTERNATIONAL CORP.
6155 CORNERSTONE COURT EAST
SUITE 125
SAN DIEGO, CA 92121 US
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Contact
JAMES BARLEY
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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
06/23/1997
Decision Date
09/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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