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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
Predetermined Change
Control Plan Authorized		 No
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