FDA 510(k) Application Details - K240023

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K240023
Device Name Thermometer, Electronic, Clinical
Applicant Shenzhen Yi Fang Blister Packaging Co., Ltd.
4/F, Bldg BC, Weixinda Industrial Park, Longteng Community
Xixiang, BaoÆan District
Shenzhen 518126 CN
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Contact Xu Junwen
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 01/03/2024
Decision Date 03/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240023


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