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 |
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