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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 K051804
Device Name ABL80 FLEX ANALYZER
Applicant
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Applicant Contact DOREEN E MILFORD
Correspondent
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Correspondent Contact DOREEN E MILFORD
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   JFP   JGS  
JIX   JJY   JPI  
Date Received07/05/2005
Decision Date 11/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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