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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 K161211
Device Name Digital Thermometer
Applicant
Biocare Asia Corporation , Ltd.
# 260, Mayun Rd., New District
Suzhou,  CN 215129
Applicant Contact KE-MIN JEN
Correspondent
Biocare Asia Corporation , Ltd.
# 260, Mayun Rd., New District
Suzhou,  CN 215129
Correspondent Contact KE-MIN JEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/28/2016
Decision Date 08/29/2016
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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