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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 K132457
Device Name FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
Applicant
Biocare Asia Corporation , Ltd.
# 260, Mayun Rd.
Suzhou,  CN 215129
Applicant Contact SHUCHI CHANG
Correspondent
Biocare Asia Corporation , Ltd.
# 260, Mayun Rd.
Suzhou,  CN 215129
Correspondent Contact SHUCHI CHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/06/2013
Decision Date 02/21/2014
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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