FDA 510(k) Application Details - K053204

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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510(K) Number K053204
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant DRAEGER MEDICAL AG & CO. KGAA
3155 QUARRY ROAD
TELFORD, PA 18969 US
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Contact MONICA FERRANTE
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/16/2005
Decision Date 02/03/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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