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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 K051873
Device Name DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
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 Received07/11/2005
Decision Date 09/20/2005
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
Recalls CDRH Recalls
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