Home / 510(k) Clearances / K200321

510(k) K200321

Novaerus NV1050 by Novaerus Us, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2020
Date Received
February 10, 2020
Clearance Type
Traditional
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)
  • K240696 — Airdog X8 Air Purifier (KJ800F-X8) (June 14, 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)
  • K130702 — AIRSONETT AIR-4 (July 23, 2013)
  • K112728 — HEPAIRX VENTILATING AIR PURIFIER (January 23, 2013)