The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Cube Air Purifier.
Device ID | K211139 |
510k Number | K211139 |
Device Name: | CUBE Air Purifier |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
Contact | Hana Jung |
Correspondent | Kyoungju Kim MDLab Inc. Room 804, 161-17, Magokjungang-ro, Gangseo-gu Seoul, KR 07788 |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-16 |
Decision Date | 2021-11-26 |