Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number	K982928
Device Name	NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
Applicant	Radiometer America, Inc. 810 Sharon Dr. Westlake,  OH  44145
Applicant Contact	VINCE SIGMUND
Correspondent	Radiometer America, Inc. 810 Sharon Dr. Westlake,  OH  44145
Correspondent Contact	VINCE SIGMUND
Regulation Number	862.1120
Classification Product Code	CHL
Subsequent Product Codes	CEM   CGA   CGZ   GKF   JGS   JHP   KHP
Date Received	08/20/1998
Decision Date	01/06/1999
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Clinical Chemistry
510k Review Panel	Clinical Chemistry
Statement	Statement
Type	Traditional
Reviewed by Third Party	No
Combination Product	No
Predetermined Change Control Plan Authorized	No
Recalls	CDRH Recalls