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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 K240220
Device Name Aulisa Temperature Module (TM0002)
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc.
6f-2, # 3-1, Yuanqu St., Nangang Dist.,
Taipei City,  TW 115
Applicant Contact Jou An Hsu
Correspondent
Taiwan Aulisa Medical Devices Technologies, Inc.
6f-2, # 3-1, Yuanqu St., Nangang Dist.,
Taipei City,  TW 115
Correspondent Contact Jou An Hsu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/26/2024
Decision Date 09/27/2024
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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