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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter To Measure Hemoglobin
510(k) Number K952725
Device Name MULTICHECK
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD L BAKER
Regulation Number864.7500
Classification Product Code
GLY  
Date Received06/14/1995
Decision Date 02/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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