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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 K192240
Device Name RAPIDPoint 500e Blood Gas System
Applicant
Siemens Healthcare Diagnostics, Inc.
2 Edgewater Drive
Norwood,  MA  02062
Applicant Contact Lois Parillon
Correspondent
Siemens Healthcare Disgnostics, Inc.
2 Edgewater Drive
Norwood,  MA  02062
Correspondent Contact Lois Parillon
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKR   JFP  
JGS   KHP   MQM  
Date Received08/19/2019
Decision Date 03/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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