Cleared Traditional

Antistatic Compact Space Chamber

K143615 · Medical Developments International Limited · Anesthesiology

Jan 2016

Decision

403d

Days

Class 2

Risk

About This 510(k) Submission

K143615 is an FDA 510(k) clearance for the Antistatic Compact Space Chamber, a Holding Chambers, Direct Patient Interface (Class II — Special Controls, product code NVP), submitted by Medical Developments International Limited (Springvale, AU). The FDA issued a Cleared decision on January 26, 2016, 403 days after receiving the submission on December 19, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K143615 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2014
Decision Date	January 26, 2016
Days to Decision	403 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

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