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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
Recalls CDRH Recalls
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