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510(k) K063125

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) by Arc Medical, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
October 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Arc Medical, Inc.

  • K090738 — THERMOFLO HCH, THERMOFLO FILTER (July 27, 2009)
  • K011212 — FILTERFLO H (December 20, 2001)
  • K982239 — CIRCUIT GUARD (August 14, 1998)
  • K924997 — EDD (March 28, 1995)
  • K924627 — XTEND CIRCUITS (TM) (April 7, 1993)

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  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)