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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 K142220
Device Name Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
Applicant
NOVA BIOMEDICAL CORPORATION
200 PROSPECT ST.
WALTHAM,  MA  02454
Applicant Contact Paul W. MacDonald
Correspondent
NOVA BIOMEDICAL CORPORATION
200 PROSPECT ST.
WALTHAM,  MA  02454
Correspondent Contact Paul W. MacDonald
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
JIX   JJS  
Date Received08/12/2014
Decision Date 10/17/2014
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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