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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 K180714
Device Name Probe Covers for Thermometers
Applicant
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd. New Taipei Industrial Park
New Taipei City,  TW 24890
Applicant Contact JM Lin
Correspondent
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd. New Taipei Industrial Park
New Taipei City,  TW 24890
Correspondent Contact JM Lin
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/19/2018
Decision Date 09/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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