Cleared Traditional

AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)

K112010 · Trudell Medical Intl. · Anesthesiology

Jul 2012

Decision

363d

Days

Class 2

Risk

About This 510(k) Submission

K112010 is an FDA 510(k) clearance for the AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC), a Holding Chambers, Direct Patient Interface (Class II — Special Controls, product code NVP), submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on July 11, 2012, 363 days after receiving the submission on July 14, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K112010 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2011
Decision Date	July 11, 2012
Days to Decision	363 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	NVP — Holding Chambers, Direct Patient Interface
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5630
Definition	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