INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE

Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration)

Draeger Medical Systems, Inc.

The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Gammaxl And Sc 6802xl With The Scio Gas Module.

Pre-market Notification Details

Device IDK040188
510k NumberK040188
Device Name:INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
ClassificationAnalyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration)
Applicant Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
ContactPenelope H Greco
CorrespondentPenelope H Greco
Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeNHP  
CFR Regulation Number868.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-28
Decision Date2004-04-14
Summary:summary

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