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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 K191251
Device Name Infared Thermometer
Applicant
Shenzhen Calibeur Industries Co., Ltd.
No. 11 Bldg., Shiguan industrial Park, Gongming,
Guangming New District
Shenzhen,  CN
Applicant Contact Weibin He
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, NanShan Medical Devices Industrial Park
Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/09/2019
Decision Date 10/15/2019
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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