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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 N. St.
Medfield,  MA  02052 -1688
Applicant Contact William J Pignato
Correspondent
Bayer Corp.
63 N. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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