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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 K012139
Device Name VAMOS ANESTHETIC GAS MONITOR
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBQ   DQA   NHO   NHQ  
Date Received07/10/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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