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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K172889
Device Name Infrared Thermometer
Applicant
Shenzhen Pacom Medical Instruments Co., Ltd.
8 Floor, B District, B Bldg., # 5
Industry Five Rd., Jianbian Community, Songgang
Shenzhen,  CN 518105
Applicant Contact Liangzhou Zhong
Correspondent
Shenzhen Pacom Medical Instruments Co., Ltd.
8 Floor, B District, B Bldg., # 5
Industry Five Rd., 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
Predetermined Change
Control Plan Authorized		 No
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