FDA 510(k) Application Details - K172795

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K172795
Device Name Thermometer, Electronic, Clinical
Applicant Shenzhen Jumper Medical Equipment Co., Ltd.
D Building, No. 71, Xintian Road, Fuyong Street, Baoan,
Shenzhen, Guangdong
Shenzhen 518102 CN
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Contact Rambo Yang
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/15/2017
Decision Date 03/14/2018
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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