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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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More FDA Info for this Product Code
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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