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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 K933832
Device Name ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
Applicant
Electromedics, Inc.
7337 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact HAROLD BRYAN
Correspondent
Electromedics, Inc.
7337 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact HAROLD BRYAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/05/1993
Decision Date 01/28/1994
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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