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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 K131126
Device Name OPTI CCA-TS2
Applicant
Opti Medical Systems, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Applicant Contact LEN OWENS
Correspondent
Opti Medical Systems, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Correspondent Contact LEN OWENS
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   GKR  
GLY   JFP   JGS   KHP  
Date Received04/22/2013
Decision Date 08/22/2013
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
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