FDA 510(k) Applications for Medical Device Product Code "BYF"
(Mask, Oxygen, Low Concentration, Venturi)

FDA 510(k) Number Applicant Device Name Decision Date
K810946 AIRLIFE, INC. ADULT & PEDIATRIC TRACHEOSTOMY MASKS 06/02/1981
K810947 AIRLIFE, INC. AIR ENTRAINMENT TRACH "T" 06/02/1981
K832725 AIRLIFE, INC. DUAL DIAL VENTURI STYLE MASK 09/20/1983
K790146 AIRLIFE, INC. MASK, PERCENTO 02/06/1979
K812066 AIRLIFE, INC. PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN 08/03/1981
K852618 ASHAI CO. LTD. OXY-DIAL 09/18/1985
K771385 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 2 JET SET 08/04/1977
K894457 DADSUN CORP., LTD. "CARNATION" TRACHEOSTOMY MASKS 10/13/1989
K860874 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC 03/19/1986
K860873 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. VENTURI MASK/ADULT & PAEDIATRIC 03/20/1986
K951652 FLEXICARE MEDICAL LTD. VENTIMASK MK IV 04/27/1995
K955483 HOSPITAK, INC. TRACH MASK MODEL (245, 246) 02/28/1996
K780626 HOSPITAK, INC. VENTURI OXYGEN MASK 05/26/1978
K760518 LANDMARK PLASTICS ADAPTER, PER-CEN-TOX-BODY 09/03/1976
K780011 RESPIRATORY CARE, INC. CONCHAPAK OXYGEN DILUTER 02/02/1978
K772127 SALTER LABS OXYGEN MASK, AIR-ENTRAINMENT 01/03/1978
K810373 TODD INDUSTRIES, INC. VENTURI MASK/DELIVERY SYSTEM #'S 03/17/1981
K810430 TODD INDUSTRIES, INC. VENTURI MASK/DELIVERY SYSTEM #6078 03/13/1981
K781325 VICKERS AMERICA MEDICAL CORP. MARKII VENTIMASKS 09/27/1978


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