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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 K193621
Device Name Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
Applicant
Dongguan E-Test Technology Co., Ltd.
Rm. 201,301. Bldg. 1, Changping Section # 1
Dongshen Rd.
Dongguan City,  CN 523588
Applicant Contact Victor Wan
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd., Guangzhou
Science Park
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/26/2019
Decision Date 11/23/2020
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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