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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 K060649
Device Name GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
Applicant
TYCO HEALTHCARE GROUP, LP
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact KEITH MARTIN
Correspondent
TYCO HEALTHCARE GROUP, LP
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact KEITH MARTIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/13/2006
Decision Date 05/22/2006
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
Recalls CDRH Recalls
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