510(k) K052332

AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER by Trudell Medical Intl. — Product Code NVP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 21, 2005
Date Received: August 26, 2005
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

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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)
K070674 — AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLO (April 11, 2007)
K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER (February 27, 2006)
K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBER (January 14, 2004)

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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)