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 |