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510(k) K070674

AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR by Trudell Medical Intl. — Product Code NVP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2007
Date Received
March 12, 2007
Clearance Type
Special
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 Intl.

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE (May 16, 2013)
  • K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (March 11, 2013)
  • K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (July 11, 2012)
  • K110136 — RESPICHAMBER VALVED HOLDING CHAMBER (April 18, 2011)
  • K090065 — AEROCHAMBER MINI VENTILATION CHAMBER (April 9, 2009)
  • K080926 — AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (August 12, 2008)
  • K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER (February 27, 2006)
  • K052332 — AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (September 21, 2005)
  • K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBER (January 14, 2004)

Other clearances for product code NVP

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