FDA 510(k) Applications for Medical Device Product Code "CBH"
(Device, Fixation, Tracheal Tube)

FDA 510(k) Number Applicant Device Name Decision Date
K811185 ACKRAD LABORATORIES N-D0-SURE 06/02/1981
K872277 ACKRAD LABORATORIES TRAKEFIT TRACHEOSTOMY TUBE HOLDER 07/21/1987
K922657 AGA MEDICAL PRODUCTS, INC. AGA TRACH TIES 07/02/1992
K810737 AIRCARE SYSTEMS ENDOTRACHEAL TUBE HOLDER 04/17/1981
K140097 APPLIED MEDICAL TECHNOLOGY, INC. AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM 09/24/2014
K882891 AUXILIARY CARE, INC. A.C.I. TRACH TIE 09/19/1988
K925386 B & B MEDICAL TECHNOLOGIES, INC. ADHESIVE E.T. TAPE 04/19/1993
K900912 B & B MEDICAL TECHNOLOGIES, INC. BABY E.T. TAPE II 08/03/1990
K871560 B & B MEDICAL TECHNOLOGIES, INC. BABY E.T. TAPE(TM) 05/22/1987
K862084 B & B MEDICAL TECHNOLOGIES, INC. E. T. TAPE ENDOTRACHEAL TUBE HOLDER 06/05/1986
K902065 B & B MEDICAL TECHNOLOGIES, INC. E.T. TAPE II 07/23/1990
K912884 B & B MEDICAL TECHNOLOGIES, INC. E.T. TAPE II 07/31/1991
K900787 B & B MEDICAL TECHNOLOGIES, INC. NASAL E.T. TAPE 03/16/1990
K935171 B & B MEDICAL TECHNOLOGIES, INC. STABILTRACH 12/02/1993
K882694 BIOSEAL FIXATION DEVICE, TRACH TUBE 08/15/1988
K902604 BLAKE MEDICAL, INC. BLAKE MEDICAL BREATHING TUBE SUPPORT 10/02/1990
K933420 BLAKE MEDICAL, INC. BREATHING TUBE SUPPORT 10/13/1993
K964399 DALE MEDICAL PRODUCTS, INC. DALE ENDOTRACHEAL TUBE HOLDER 270/280 01/28/1997
K951491 DALE MEDICAL PRODUCTS, INC. DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS 04/24/1995
K905231 DALE MEDICAL PRODUCTS, INC. DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. 01/14/1991
K941384 ERGOMED, INC. TRAKEEZ 04/19/1994
K942016 GARRETT MEDICAL PRODUCTS TRACH TIE, VENTILATOR TUBING HOLDER 05/24/1994
K933781 HAMMER-PLANE, INC. ANTI-DISCONNECTION MECHANISM 09/22/1993
K942529 HEALTH CARE CONTRACTS, INC. HCI TUBE STABILIZER 06/14/1995
K802601 HUDSON OXYGEN THERAPY SALES CO. ENDOTRACHEAL TUBE HOLDER 12/18/1980
K851874 KINETIC CONCEPTS, INC. OR TUBE RESTRAINT 08/08/1985
K950318 KING SYSTEMS CORP. FLEX BLUE 02/13/1995
K843790 LAERDAL CALIFORNIA, INC. TRACHEAL TUBE FIXATION DEVICE 03/11/1985
K924551 M. IMONTI AND ASSOCIATES INC., ENDO TRACHEA TUBE FIXATION 12/08/1992
K864526 MATHEW MEDICAL CO. ENDOTRACHEAL TUBE HOLDER 05/21/1987
K940448 MEDICAL ACCESSORY SERVICES, INC. NETOH ENDOTRACHEAL TUBE HOLDER 02/22/1994
K921698 N-C-N PRODUCTS CO. CN ENDOTRACHEAL TUBE HOLDER 09/15/1992
K934288 NEO-TECH, INC. HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR 06/09/1994
K902896 NIKOMED U.S.A., INC. 49-610 NIKO-NOSE FIXATION TAPE 10/23/1990
K781695 OLYMPIC MEDICAL CORP. LUBE-LOK 11/01/1978
K936094 PREPARE, INC. PREPARE LOCK 02/03/1994
K920691 R. LEWIS, INC. THE LEWIS TUBE HOLDER 03/18/1992
K882079 RESPIRONICS, INC. RESPIRONIC'S INFANT SECUREEASY 08/19/1988
K822794 RESPIRONICS, INC. RESPIRONICS ENDO TUBE CONTROL SYS 10/22/1982
K860845 RESPIRONICS, INC. RESPIRONICS SECUREASY 03/13/1986
K830706 RND MEDICAL PRODUCTS, INC. E.T. STRAP #6000 04/28/1983
K904974 ROTEK CORP. TRACH COLLAR 01/11/1991
K872832 ROTEK CORP. TRACH COLLAR 09/04/1987
K942395 S.T.I. MEDICAL PRODUCTS CORP. ENDOTRACHEAL TUBE HOLDER 06/30/1994
K903539 SALTER LABS SALTER LABS MODEL #1015 12/17/1990
K950930 THE VARNER GROUP, INC. TRACHE-TITE 03/22/1995
K900236 VENTLAB CORP. ET-RESTRAINT CAT. # ER 4000 02/02/1990


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