FDA 510(k) Application Details - K952172

Device Classification Name Plethysmograph, Impedance

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510(K) Number K952172
Device Name Plethysmograph, Impedance
Applicant HEMO SAPIENS, INC.
19211 EDGEHILL DR.
IRVINE, CA 92612-3505 US
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Contact B. BO SRAMEK
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 05/08/1995
Decision Date 06/10/1997
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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