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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 K021713
Device Name STAT PROFILE PHOX PLUS C ANALYZER
Original Applicant
NOVA BIOMEDICAL CORP.
200 prospect st.
waltham,  MA  02454 9141
Original Contact paul w macdonald
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKR   JEP  
JGS   JIX   JKS   JPI   JPK  
Date Received05/23/2002
Decision Date 07/25/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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