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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K191004
Device Name Advocate Non-Contact Infrared Thermometer
Applicant
BroadMaster Biotech, Corp.
1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist.
Taoyuan,  TW 32057
Applicant Contact Jen Ke-Min
Correspondent
Chinese-European Industrial Research Society
No. 58, Fu-Chiun St
Hsin-Chu City,  TW 30067
Correspondent Contact Jen Ke-Min
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/16/2019
Decision Date 09/05/2019
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
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