Cleared Traditional

K122252 - SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
(FDA 510(k) Clearance)

K122252 · Medical Developments International · Anesthesiology

Nov 2013

Decision

474d

Days

Class 2

Risk

K122252 is an FDA 510(k) clearance for the SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS. This device is classified as a Holding Chambers, Direct Patient Interface (Class II — Special Controls, product code NVP).

Submitted by Medical Developments International (St Leonards, AU). The FDA issued a Cleared decision on November 13, 2013, 474 days after receiving the submission on July 27, 2012.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630. 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.

Submission Details

510(k) Number	K122252 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2012
Decision Date	November 13, 2013
Days to Decision	474 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