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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 K954632
Device Name SIEMENS SC 9000 ETCO2 MODULE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact THOMAS CONNELLY
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact THOMAS CONNELLY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/06/1995
Decision Date 02/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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