FDA 510(k) Application Details - K172894

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K172894
Device Name Thermometer, Electronic, Clinical
Applicant Shenzhen Jiacom Technology Co ., Ltd
No. A6 Building, Silicon Valley Power
Qinghu Park, Longhua Street, BaoÆan Dist
Shenzhen 518109 CN
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Contact Luo Tianfeng
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/22/2017
Decision Date 05/17/2018
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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