FDA.reportPublic FDA data

510(k) K240569

Device
FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
Applicant
Fink Engineering Pty, Ltd.
510(k) number
K240569
Product code
CBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-21
Date received
2024-02-29
Regulation
868.5470
Classification name
Chamber, Hyperbaric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eric Fink
Address
14 Premier Circuit Warana AU 4575 4575

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220290Revitalair 430+Us Hyperbaric Network2023-05-04
K171899Revitalair 430FOxavita Srl2019-11-22
K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.2017-03-22
K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.2016-04-29
K140559SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.2014-05-30
K102831RSI 4200Reimers Systems, Inc.2011-08-19
K092991O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)Environmental Tectonics Corp.2010-08-13
K101262FLEXI-LITEPressure-Tech, Inc.2010-06-10
K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.2010-04-26
K082455RECTANGULAR MULTIPLACE HYPERBARIC CHAMBERGulf Coast Hyperbarics, Inc.2009-05-22
K081506HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMSHyperbaric America, LLC2008-07-25
K072427SIGMA SERIES HYPERBARIC CHAMBERPerry Baromedical Corp.2008-06-11
K072757DIVE AND SHALLOW AND GRAND DIVESummit TO Sea2008-02-08
K060739MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307Khrunichev State Research & Production Space Centr2006-07-21
K053498HYPEROX 101Wjo, Inc.2006-03-15