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510(k) K232933

AirKEE P900 by Healkee Medical Pte, Ltd. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2024
Date Received
September 20, 2023
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

Other clearances by Healkee Medical Pte, Ltd.

  • K232642 — AirKEE T900 (May 23, 2024)

Other clearances for product code FRA

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  • K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008 (August 1, 2024)
  • K232642 — AirKEE T900 (May 23, 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)
  • K212824 — Bluezone Model RX-450 Air Purifier (February 17, 2022)