Fever Garde

Thermometer, Electronic, Clinical

HuBDIC Co., Ltd.

The following data is part of a premarket notification filed by Hubdic Co., Ltd. with the FDA for Fever Garde.

Pre-market Notification Details

Device IDK191978
510k NumberK191978
Device Name:Fever Garde
ClassificationThermometer, Electronic, Clinical
Applicant HuBDIC Co., Ltd. 301, 53 Jeonpa-ro, Mana-gu, Anyang-si, Gyongg-do Anyang-si,  KR 14084
ContactShin Jae-ho
CorrespondentPeter Chung
Plus Global 300 Atwood Pittsburgh,  PA  15213
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-24
Decision Date2020-12-18

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