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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 K151856
Device Name ABL80 FLEX CO-OX with AQURE connectivity
Applicant
SENDX MEDICAL INC.
1945 PALOMAR OAKS WAY
CARLSBAD,  CA  92011
Applicant Contact Vibeke Agerlin
Correspondent
RADIOMETER MEDICAL APS.
AAKANDEVEJ 21
BROENSHOEJ,  DK 2700
Correspondent Contact LASSE POST MOLLER
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   DQA   GHS  
GKR   JFP   JGS   JPI  
Date Received07/08/2015
Decision Date 08/06/2015
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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