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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 K862958
Device Name AMR RESEARCH TONOMETER
Applicant
Associated Medical Representatives
890 W. 70th Pl.
P.O. Box 21345
Denver,  CO  80221
Applicant Contact CAROL E FINKBEINER
Correspondent
Associated Medical Representatives
890 W. 70th Pl.
P.O. Box 21345
Denver,  CO  80221
Correspondent Contact CAROL E FINKBEINER
Regulation Number862.1660
Classification Product Code
LCH  
Date Received08/05/1986
Decision Date 11/24/1986
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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