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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 K172427
Device Name AViTA Radar Thermo NT16 Series IR Thermometer
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., San-Chung District
New Taipei City,  TW 24158
Applicant Contact Steven Jhou
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., San-Chung District
New Taipei City,  TW 24158
Correspondent Contact Steven Jhou
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/10/2017
Decision Date 04/19/2018
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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