FDA 510(k) Application Details - K003550

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

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510(K) Number K003550
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GREEN
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/17/2000
Decision Date 03/07/2001
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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