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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 K112929
Device Name THERMOFLASH(TM) INFRARED THERMOMETER
Applicant
VISIOMED GROUP SA
21, AVENUE VICTOR HUGE
paris,  FR 75116
Applicant Contact eric sebban
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
camas,  WA  98607 -9526
Correspondent Contact marc m mouser
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/03/2011
Decision Date 10/18/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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