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510(k) K241339

Besmed Bacterial Filter and HMEF by Besmed Health Business Corp — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2024
Date Received
May 13, 2024
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 Besmed Health Business Corp

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  • K150591 — Besmed Reusable Jet Nebulizer (June 30, 2015)
  • K143150 — CO2 monitoring line with and without in-line filter (February 5, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K133873 — TRIBALL INCENTIVE SPIROMETER (April 4, 2014)
  • K091272 — BESMED JET NEBULIZER BOTTLE SET (November 10, 2009)
  • K031374 — BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 (November 28, 2003)
  • K031375 — BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 (November 20, 2003)

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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)
  • K191909 — HepaShield Bacterial Viral Breathing System Filter (March 23, 2020)