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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 K130231
Device Name NON-CONTACT INFRARED THERMOMETER
Applicant
JINXINBAO ELECTRONIC CO.,LTD
ROOM 404, BLDG 7, JINHUICHANG HOMELAND
LIUHONGQIAO RD.
WENZHOU, ZHEJIANG,  CN 325000
Applicant Contact HELEN NAN
Correspondent
JINXINBAO ELECTRONIC CO.,LTD
ROOM 404, BLDG 7, JINHUICHANG HOMELAND
LIUHONGQIAO RD.
WENZHOU, ZHEJIANG,  CN 325000
Correspondent Contact HELEN NAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/29/2013
Decision Date 10/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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