FDA 510(k) Application Details - K994188

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

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510(K) Number K994188
Device Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Applicant AGILENT TECHNOLOGIES, GMBH
HERRENBERGER STRASSE 130
BOEBLINGEN 71034 DE
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Contact HERBERT VAN DYK
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Regulation Number 868.1500

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Classification Product Code CBQ
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Date Received 12/13/1999
Decision Date 05/19/2000
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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