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510(k) K210558

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber by Thayer Medical Corporation — Product Code NVP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2022
Date Received
February 25, 2021
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 Thayer Medical Corporation

  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (May 19, 2017)
  • K111570 — MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (September 29, 2011)

Other clearances for product code NVP

  • K242667 — AeroChamber2go Anti-Static Valved Holding Chamber (January 15, 2025)
  • 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)