FDA.reportPublic FDA data

510(k) K242667

Device
AeroChamber2go Anti-Static Valved Holding Chamber
Applicant
Trudell Medical International
510(k) number
K242667
Product code
NVP
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-15
Date received
2024-09-05
Regulation
868.5630
Classification name
Holding Chambers, Direct Patient Interface
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Marianne Tanton
Address
725 Baransway Dr. London CA N5V 5G4 N5V 5G4

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NVP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210558LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical Corporation2022-04-01
K181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)Trudell Medical International2019-01-11
K160109Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberThayer Medical Corporation2017-05-19
K143615Antistatic Compact Space ChamberMedical Developments International Limited2016-01-26
K140062FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBERFsc Laboratories, Inc.2014-10-03
K122252SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUSMedical Developments International2013-11-13
K130598INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBERInspirx, Inc.2013-06-05
K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)Trudell Medical Intl.2012-07-11
K110293OPTICHAMBER DIAMOND VALVED HOLDING CHAMBERRespironics New Jersey, Inc.2011-08-09
K101348AGACHAMBER SPACERAga Plastic Ind. Com. Ltda.2011-04-29
K110136RESPICHAMBER VALVED HOLDING CHAMBERTrudell Medical Intl.2011-04-18
K101136FISIO CHAMBER SPACEKoo (Shanghai) Industries Co., Ltd.2011-01-28
K080100WATCHHALERActivaero America, Inc.2008-06-30
K070674AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATORTrudell Medical Intl.2007-04-11
K052332AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBERTrudell Medical Intl.2005-09-21