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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K122539
Models 10844215, 10844217
Device Name MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 edgewater drive
norwood,  MA  02062
Original Contact steven goldberg
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/21/2012
Decision Date 04/19/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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