CUBE Air Purifier
K-Number: K211139 · 2021-11-26
ApplicantSamsung Electronics Co., Ltd.
Decision Date2021-11-26
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CUBE Air Purifier is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under approval number K211139. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CUBE Air Purifier?
CUBE Air Purifier is a medical device that received FDA 510(k) clearance on 2021-11-26. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K211139.
When was CUBE Air Purifier approved by the FDA?
CUBE Air Purifier received FDA 510(k) clearance on 2021-11-26, under approval number K211139.
What company makes CUBE Air Purifier?
CUBE Air Purifier is manufactured by Samsung Electronics Co., Ltd..
What is the FDA product code for CUBE Air Purifier?
The FDA product code for CUBE Air Purifier is FRA.
Other Devices by Samsung Electronics Co., Ltd.
Related Devices (Code: FRA)
K161468Transformair Indoor Air PurifierTransformair, LLC
K201220Aerus Medical Guardian,model F170AAerus Medical, LLC
K200500Molekule Air Pro RXMolekule, Inc.
K211194Molekule Air ProMolekule, Inc.
K202766EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd.
K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.