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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
510(k) Number K904163
Device Name CLINICAL BLOOD GAS MIXTURES
Applicant
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Applicant Contact LYLE FEELY
Correspondent
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Correspondent Contact LYLE FEELY
Regulation Number862.1660
Classification Product Code
LCH  
Date Received09/11/1990
Decision Date 11/01/1990
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
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