CUBE Air Purifier

Purifier, Air, Ultraviolet, Medical

Samsung Electronics Co., Ltd.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Cube Air Purifier.

Pre-market Notification Details

Device IDK211139
510k NumberK211139
Device Name:CUBE Air Purifier
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
ContactHana Jung
CorrespondentKyoungju Kim
MDLab Inc. Room 804, 161-17, Magokjungang-ro, Gangseo-gu Seoul,  KR 07788
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-16
Decision Date2021-11-26

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