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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K834099
Device Name BLOOD GLUCOSE MONITOR
Applicant
Healthdyne, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Healthdyne, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/28/1983
Decision Date 02/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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