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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K830592
Device Name DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
Applicant
ELECTROMEDICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ELECTROMEDICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/24/1983
Decision Date 05/18/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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