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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 K050837
Device Name REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE
Applicant
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/01/2005
Decision Date 04/27/2005
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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