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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K771994
Device Name ELECTROTHERM MODEL HT-1
Applicant
Electromedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Electromedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/21/1977
Decision Date 11/02/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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