FDA 510(k) Application Details - K081823

Device Classification Name Plethysmograph, Pressure

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510(K) Number K081823
Device Name Plethysmograph, Pressure
Applicant VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact THOMAS RUST
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Regulation Number 868.1750

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Classification Product Code CCM
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Date Received 06/27/2008
Decision Date 05/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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