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510(k) K211139

CUBE Air Purifier by Samsung Electronics Co., Ltd. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2021
Date Received
April 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

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  • K213452 — GEMS-H (April 21, 2022)
  • K201560 — Auto Lung Nodule Detection (August 31, 2021)
  • K201168 — ECG Monitor App (August 4, 2020)

Other clearances for product code FRA

  • K252128 — Zener® (model ZEN-001-B1) (September 15, 2025)
  • K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008 (August 1, 2024)
  • K232642 — AirKEE T900 (May 23, 2024)
  • K232933 — AirKEE P900 (May 16, 2024)
  • K232645 — Airgle Room Air Purifier (February 16, 2024)
  • K221540 — Synexis Sphere Rx (June 14, 2023)
  • K222702 — RGS; RGS Mini (June 2, 2023)
  • K223328 — Purgo (November 30, 2022)
  • K213753 — Purgo (June 1, 2022)
  • K212644 — Aura Storm (May 26, 2022)