FDA 510(k) Applications for Medical Device Product Code "BYG"
(Mask, Oxygen)

FDA 510(k) Number Applicant Device Name Decision Date
K790163 AIRLIFE, INC. AEROSOL MASK 02/16/1979
K790164 AIRLIFE, INC. OXYGEN MASK REBREATHER 02/06/1979
K790166 AIRLIFE, INC. OXYGEN MASK, ADULT VINYL 03/16/1979
K790165 AIRLIFE, INC. OXYGEN MASK-HIGH CONCENTRATION 02/06/1979
K811711 AIRLIFE, INC. PEDIATRIC OXYGEN MASKS 07/01/1981
K802323 AIRLIFE, INC. PEDIATRIC OXYGEN OR AEROSOL MASKS, 10/03/1980
K852626 ASHAI CO. LTD. AERO-MASK ONE 09/18/1985
K852629 ASHAI CO. LTD. AERO-MASK TWO 09/18/1985
K852623 ASHAI CO. LTD. OXY-ONE 09/18/1985
K852624 ASHAI CO. LTD. OXY-TWO 09/18/1985
K772141 B & F MEDICAL PRODUCTS, INC. AEROSOL & OXYGEN MASKS 01/03/1978
K823532 B & F MEDICAL PRODUCTS, INC. STOCK #64091-PEDIATRIC OXYGEN MASK 01/05/1983
K913501 B & F MEDICAL PRODUCTS, INC. TRACHEOSTOMY MASK 01/13/1992
K904195 BP LTD. DISPOSABLE FACE MASK 09/25/1990
K870206 BRUNSWICK MFG. CO., INC. CRYSTAL MASK 02/20/1987
K896773 CADEMA MEDICAL PRODUCTS, INC. DISPOSABLE FACE MASK 01/12/1990
K850626 CATHAY CONSOLIDATED, INC. CARNATION OXYGEN 03/12/1985
K851466 DADSUN CORP., LTD. CARNATION - OXYGEN MASK 06/19/1985
K953039 DADSUN CORP., LTD. VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS 09/15/1995
K921499 DEVILBISS HEALTH CARE, INC. SEAL RING FOR NASAL CPAP 09/17/1992
K860870 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. AEROSOL MASKS/ADULT & PAEDIATRIC 03/19/1986
K860869 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. MEDIUM CONCENTRATION OXYGEN MASKS 03/19/1986
K860871 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC 03/19/1986
K945482 FVTNKS DISPOSABLE, CPAP OXYGEN MASK 09/19/1995
K760941 GENE R. BALDWIN MASK ARTIFICIAL RESPIRATION 01/12/1977
K924069 GUJARAT SURGICO, LTD. SURGICO OXYGEN MASK 02/04/1993
K962848 HANS RUDOLPH, INC. HANS RUDOLPH NASAL CPAP MASK 10/16/1996
K781055 HOSPITAK, INC. FACE TENTS 07/17/1978
K781741 INHAL-O-TECH MEDICAL PLASTIC MASK, BI FLO NASAL OXYGEN 12/01/1978
K760329 INHAL-O-TECH MEDICAL PLASTIC MASK, DISPOSABLE OXYGEN THERAPY 09/30/1976
K812208 KAMEI INTL. CORP. NASAL OXYGEN CANNULA OXYGEN MASK 08/25/1981
K874092 LIFE SUPPORT PRODUCTS, INC. MASK, OXYGEN 02/11/1988
K760219 MANNER MEDICAL PRODUCTS MASKA, OXYGEN VINYL D-SP. SINGLE USE 08/03/1976
K905288 MED-TEK INNOVATIONS, INC. ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES 04/09/1991
K940887 MEDIC-AID LTD. SYSTEM 22 ADULT MASK 04/19/1994
K940888 MEDIC-AID LTD. SYSTEM 22 PAEDIATRIC MASK 04/19/1994
K894642 MEDICAL INDUSTRIES AMERICA, INC. SLEEPAP MASK 10/19/1989
K931952 MEDWAY MEDWAY OXYGEN MASK 08/20/1993
K790934 MEM MEDICAL, INC. OXYGEN BARB M-552 05/21/1979
K770995 OHIO MEDICAL PRODUCTS AEROSOL MASK 06/27/1977
K890193 PURITAN BENNETT CORP. SINGLE PATIENT USE NASAL (CPAP) CIRCUIT 03/14/1989
K942907 RESPAN PRODUCTS, INC. JEMSDAL MASK 08/31/1994
K865047 SALTER LABS SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE 02/10/1987
K912633 SALTER LABS SALTER LABS INFANT MEDIUM CONCENTRATION MASK 07/19/1991
K823141 SEVEN HARVEST INTL. IMPORT & EXPORT OXYGEN MASKS 11/29/1982
K913383 SPECIALTY PACKAGING PRODUCS, INC. OXYGEN MASKS 81420, 81421, 81471 & 81461 10/18/1991
K913455 SPECIALTY PACKAGING PRODUCS, INC. OXYGEN MASKS 82400 & 82405 10/02/1991
K913275 SPECIALTY PACKAGING PRODUCS, INC. VENTURI OXYGEN MASK 10/10/1991
K892434 THE KENDAL CO. KENDALL CURITY OXYGEN MASK 08/15/1989
K810340 TODD INDUSTRIES, INC. ADULT MASKS & PEDIATRIC MASKS 03/17/1981
K904719 TRI/BOR MEDICAL, INC. DISPOSABLE FACE MASK 01/02/1991
K963298 VECTOR, INC. FIRST AID KIT(S) 11/06/1996
K801883 VITAL SIGNS, INC. PEEP FACE MASK 09/09/1980
K945472 WESTMED INTL. WESTMED PEDIATRIC AND ADULT AEROSOL MASK 02/07/1995
K953464 WESTMED, INC. WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK 09/18/1995


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact