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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K040188
Device Name INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
Applicant
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number868.1500
Classification Product Code
NHP  
Subsequent Product Code
MHX  
Date Received01/28/2004
Decision Date 04/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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