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510(k) K242667

AeroChamber2go Anti-Static Valved Holding Chamber by Trudell Medical International — Product Code NVP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
September 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holding Chambers, Direct Patient Interface
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

Other clearances by Trudell Medical International

  • K203400 — Corrugated tube with mouthpiece accessory (June 14, 2021)
  • K200063 — AeroEclipse* ONE BAN (July 17, 2020)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (January 11, 2019)
  • K173918 — VersaPAP Positive Airway Pressure (PAP) Device (August 17, 2018)
  • K173825 — MC 300R* Nebulizer (May 2, 2018)
  • K173367 — MC 300* Nebulizer (February 28, 2018)
  • K150173 — Aerobika OPEP Devive with Manometer (October 15, 2015)

Other clearances for product code NVP

  • K210558 — LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (April 1, 2022)
  • K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (January 11, 2019)
  • K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (May 19, 2017)
  • K143615 — Antistatic Compact Space Chamber (January 26, 2016)
  • K140062 — FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER (October 3, 2014)
  • K122252 — SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS (November 13, 2013)
  • K130598 — INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER (June 5, 2013)
  • K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (July 11, 2012)
  • K110293 — OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (August 9, 2011)
  • K101348 — AGACHAMBER SPACER (April 29, 2011)