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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 K131703
Device Name NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
Applicant
NOVA BIOMEDICAL CORPORATION
200 Prospect St
WALTHAM,  MA  02454
Applicant Contact PAUL W MCDONALD
Correspondent
NOVA BIOMEDICAL CORPORATION
200 Prospect St
WALTHAM,  MA  02454
Correspondent Contact PAUL W MCDONALD
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKF   JFP  
JGS   JIX   JJS  
Date Received06/11/2013
Decision Date 03/25/2014
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
Recalls CDRH Recalls
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