FDA 510(k) Application Details - K182437

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K182437
Device Name Thermometer, Electronic, Clinical
Applicant Shenzhen Jumper Medical Equipment Co.,Ltd.
D Building, No. 71, Xintian Road, Fuyong Street, Baoan
Shenzhen 518100 CN
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Contact Tom Tom
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/07/2018
Decision Date 05/05/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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