FDA 510(k) Application Details - K072061

Device Classification Name Plethysmograph, Volume

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510(K) Number K072061
Device Name Plethysmograph, Volume
Applicant VIASYS HEALTHCARE GMBH
22745 SAVI RANCH PKWY.
YORBA LINDA, CA 92887 US
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Contact Yvette Lloyd
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Regulation Number 868.1760

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Classification Product Code JEH
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Date Received 07/27/2007
Decision Date 04/22/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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