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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 K080370
Device Name ABL 80 CO-OX SYSTEM
Applicant
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Applicant Contact MARK A DZENDZEL
Correspondent
Sendx Medical, Inc.
1945 Palomar Oaks Way
Carlsbad,  CA  92011
Correspondent Contact MARK A DZENDZEL
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
GLY   JFP   JGS   JIX   JJY   JPI  
Date Received02/12/2008
Decision Date 07/31/2008
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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