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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 K943643
Device Name STAT PROFILE ULTRA 11 ANALYZER
Applicant
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD
Correspondent
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CFA   CGA   JFP   JGS  
JIX   JPI   JPK   KHP  
Date Received07/27/1994
Decision Date 12/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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