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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, Oxygen, Gaseous-Phase
510(k) Number K123195
Device Name CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
Applicant
Ge Healthcare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Applicant Contact RAUNO RUOHO
Correspondent
Ge Healthcare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Correspondent Contact RAUNO RUOHO
Regulation Number868.1720
Classification Product Code
CCL  
Date Received10/11/2012
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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