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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 K905775
Device Name SIEMENS ETCO2 CARTRIDGE
Applicant
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact ROBERT R MURFITT
Correspondent
Siemens Medical Electronics
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact ROBERT R MURFITT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/27/1990
Decision Date 03/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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