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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 K052849
Device Name INFRARED THERMOMETER, FDIR-V1
Applicant
FAMIDOC TECHNOLOGY CO., LTD
3RD FLOOR, EAST BLOCK 4
CHEGONGMIAO ANHUA INDUST. ZONE
SCHENZHEN, GUANGDONG,  CN
Applicant Contact MR. STEELJIN
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 Received10/11/2005
Decision Date 10/26/2005
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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