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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 K003550
Device Name INFINITY ETCO2 + RESPIRATORY MECHANICS POD
Applicant
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact PENELOPE H GREEN
Correspondent
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact PENELOPE H GREEN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
BZK  
Date Received11/17/2000
Decision Date 03/07/2001
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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