FDA 510(k) Application Details - K092324

Device Classification Name Oximeter

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510(K) Number K092324
Device Name Oximeter
Applicant VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact THOMAS RUST
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/04/2009
Decision Date 09/03/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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