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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 K893391
Device Name MI-328, MI-316, MI-388 DIGITAL THERMOMETER
Applicant
Nam Tai Electronic & Electrical Products, Ltd.
12/F, 13/F Century Centre
44-46 Hung To Rd., Kwun Tong
Kln, Hong Kong,  HK
Applicant Contact MURAKAMI
Correspondent
Nam Tai Electronic & Electrical Products, Ltd.
12/F, 13/F Century Centre
44-46 Hung To Rd., Kwun Tong
Kln, Hong Kong,  HK
Correspondent Contact MURAKAMI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/01/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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