CUBE Air Purifier— 510(k) K211139

Name: FDA 510(k) clearance K211139
Creator: U.S. Food and Drug Administration
Published: 2021-11-26

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K211139 for CUBE Air Purifier, Substantially Equivalent on 2021-11-26. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2021-04-16
Decision date: 2021-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.