Home / 510(k) Clearances / K240696

510(k) K240696

Airdog X8 Air Purifier (KJ800F-X8) by Suzhou Beiang Smart Technology Co., Ltd. — Product Code FRF

K240696 is an FDA 510(k) premarket notification submitted by Suzhou Beiang Smart Technology Co., Ltd. for the device "Airdog X8 Air Purifier (KJ800F-X8)". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2024
Date Received
March 14, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

Other clearances for product code FRF

  • K251872 — Biomoneta Avata Rx (November 14, 2025)
  • K242102 — CerroZone Mini (November 19, 2024)
  • K223835 — MA-40, MA-112 (September 18, 2023)
  • K222416 — RIA Safeguard (May 1, 2023)
  • K211507 — Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (November 22, 2022)
  • K220990 — Qorda QD1 (September 14, 2022)
  • K220298 — CerroZone Mobile (July 1, 2022)
  • K200321 — Novaerus NV1050 (December 28, 2020)
  • K130702 — AIRSONETT AIR-4 (July 23, 2013)
  • K112728 — HEPAIRX VENTILATING AIR PURIFIER (January 23, 2013)

FDA data resources