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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 K212257
Device Name Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
Applicant
Alicn Medical Shenzhen, Inc.
Rm. 410, Bldg. A, 3rd Sub-Park, Leibo Zhongcheng Life
Science Park, Kengzi
Shenzhen,  CN 518118
Applicant Contact Fang Meisong
Correspondent
Alicn Medical Shenzhen, Inc.
Rm. 410, Bldg. A, 3rd Sub-Park, Leibo Zhongcheng Life
Science Park, Kengzi
Shenzhen,  CN 518118
Correspondent Contact Fang Meisong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/19/2021
Decision Date 05/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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