FDA 510(k) Application Details - K201582

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K201582
Device Name Thermometer, Electronic, Clinical
Applicant Zhongshan Jinli Electronic Weighingá Equipment Co., Ltd.
283rd South MinÆan Road, Xiaolan Town, Zhongshan City
Zhongshan 528416 CN
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Contact Jerry Liang
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 06/11/2020
Decision Date 01/15/2021
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



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