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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K040847
Device Name MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
Applicant
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact GALE E WINARSKY
Correspondent
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact GALE E WINARSKY
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBQ   CBR   CBS   DQA   NHO  
NHP   NHQ  
Date Received04/01/2004
Decision Date 06/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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