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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 K202603
Device Name Temp Pal
Applicant
Iweecare Co., Ltd.
2f, # 121, Sec. 2, Linong St., Beitou Dist.,
Taipei City,  TW 112
Applicant Contact Glen Tseng
Correspondent
Iweecare Co., Ltd.
2625 Middlefield Rd., #113
Palo Alto,  CA  94306
Correspondent Contact Shao-Chun Chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/08/2020
Decision Date 07/22/2021
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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