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CBF — Chamber, Hyperbaric Class II

FDA Device Classification

Classification Details

Product Code
CBF
Device Class
Class II
Regulation Number
868.5470
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240569fink engineering ptyFESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberNovember 21, 2024
K220290us hyperbaric networkRevitalair 430+May 4, 2023
K171899oxavitaRevitalair 430FNovember 22, 2019
K163109oxyheal medical systemsOxyHeal 4000 Multiplace Hyperbaric Chamber FamilyMarch 22, 2017
K152223oxyheal medical systemsRectangular Multiplace Hyperbaric Chamber System Product Family with TouchscreenApril 29, 2016
K140559sechrist industriesSECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERMay 30, 2014
K102831reimers systemsRSI 4200August 19, 2011
K092991environmental tectonicsO.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)August 13, 2010
K101262pressure-techFLEXI-LITEJune 10, 2010
K100268sechrist industriesSECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERApril 26, 2010
K082455gulf coast hyperbaricsRECTANGULAR MULTIPLACE HYPERBARIC CHAMBERMay 22, 2009
K081506hyperbaric americaHYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMSJuly 25, 2008
K072427perry baromedicalSIGMA SERIES HYPERBARIC CHAMBERJune 11, 2008
K072757summit to seaDIVE AND SHALLOW AND GRAND DIVEFebruary 8, 2008
K060739khrunichev state research and production space centrMONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307July 21, 2006
K053498wjoHYPEROX 101March 15, 2006
K052866oxyheal health groupOXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBERDecember 13, 2005
K051759performance hyperbaricsFLEXI-LITE, MODEL FL-V1.2November 17, 2005
K052713sechrist industriesMODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBEROctober 28, 2005
K040145ata hyperbaric chamber manufacturingATA HCM MONOPLACE HYPERBARIC SYSTEMMay 4, 2005