FDA 510(k) Application Details - K040188

Device Classification Name Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)

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510(K) Number K040188
Device Name Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Applicant Draeger Medical Systems, Inc.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GRECO
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Regulation Number 868.1500

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Classification Product Code NHP
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Date Received 01/28/2004
Decision Date 04/14/2004
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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