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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 K141907
Device Name STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
Applicant
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MACDONALD
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKF   JFP  
JGS   JIX   JJS   KHP  
Date Received07/15/2014
Decision Date 05/29/2015
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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