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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 K152508
Device Name Ageless Health Medical Digital Thermometer
Applicant
Dongguan Ageless Health Industrial Co., Ltd.
3/F, A1 Bldg
Dongshen Sima Industrial Area, #33 Shenbei Rd.
Dongguan,  CN 523560
Applicant Contact VICTOR WAN
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suit 306, Kecheng Mansion. #121 Science Rd.,
Guangzhou Science Park
Guangzhou,  CN 510663
Correspondent Contact CECILIA CENG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/02/2015
Decision Date 12/31/2015
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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