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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 K061942
Device Name TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/10/2006
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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