FDA 510(k) Application Details - K970603

Device Classification Name Plethysmograph, Impedance

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510(K) Number K970603
Device Name Plethysmograph, Impedance
Applicant CMC SENSE-IT, INC.
810 SOUTH 1ST. ST. #120
HOPKINS, MN 55343 US
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Contact CLARK VIER
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 02/18/1997
Decision Date 04/01/1997
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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