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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 K172889
Device Name Infrared Thermometer
Applicant
Shenzhen Pacom Medical Instruments Co., Ltd.
8 Floor, B District, B Building, No. 5
Industry five road, Jianbian Community, Songgang
shenzhen,  CN 518105
Applicant Contact liangzhou zhong
Correspondent
Shenzhen Pacom Medical Instruments Co., Ltd.
8 Floor, B District, B Building, No. 5
Industry five road, Jianbian Community, Songgang
shenzhen,  CN 518105
Correspondent Contact liangzhou zhong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2017
Decision Date 05/25/2018
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
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