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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
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