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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 K002738
Device Name BAYER RAPIDPOINT 400 SYSTEM
Applicant
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact William J Pignato
Correspondent
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Correspondent Contact William J Pignato
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKF   JFP  
JGS  
Date Received09/01/2000
Decision Date 12/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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