FDA 510(k) Applications for Medical Device Product Code "CAE"
(Airway, Oropharyngeal, Anesthesiology)

FDA 510(k) Number Applicant Device Name Decision Date
K780601 ABCO DEALERS, INC. AIRWAYS 05/19/1978
K810099 AMERICAN HOSPITAL SUPPLY CORP. AIRWAYS-OROPHARYNGEAL 02/05/1981
K891926 ANTHONY DON MICHAEL, M.D. KISS OF LIFE 08/21/1989
K881065 APPLIED CONVERGENT TECHNOLOGIES, INC. RESUS-AID 07/14/1988
K822727 ARMSTRONG IND., INC. RESCUER 09/28/1982
K832512 ARTEC ENVIRONMENTAL MONITORING DIVISION AIRWAY MASKS 01/17/1984
K861054 B & F MEDICAL PRODUCTS, INC. DISPOSABLE RESCUE BREATHING DEVICE 04/09/1986
K861482 BEGLEY ENTERPRISES, INC. RESUSIKIT 06/17/1986
K913680 CHAIN PLASTICS OPERATIONS, INC. BERMAN INTUBATING/PHARYNGEAL AIRWAY 10/10/1991
K791799 CONPHAR, INC. CONPHAR AIRWAYS 09/19/1979
K861540 DRYDEN CORP. DISPOSABLE BERMAN AND GUEDEL AIRWAYS 05/02/1986
K891586 DYNAREX CORP. ORAL AIRWAY 05/11/1989
K883593 ECOLAB, INC. #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY 09/30/1988
K821308 ESP PLASTICS, INC. ESPREE' GUEDEL ESPREE" BERMAN AIRWAY 05/21/1982
K810651 FIRST INDUSTRIES, INC. ORAL AIRWAYS 03/31/1981
K800881 HARVARD LABORATORIES DISPOSABLE BERMAN AIRWAYS 05/08/1980
K760488 HUDSON OXYGEN THERAPY SALES CO. AIRWAY, DUAL CHANNEL 09/03/1976
K832471 INMED CORP. ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III 09/12/1983
K850248 INMED CORP. DISPOSABLE GUEDEL AIRWAY 03/12/1985
K904834 INTAVENT INTL. S.A. INTAVENT LARYNGEAL MASK 07/26/1991
K854029 JOHN H. HARRISON RESPIRATORY RESUSCITATION DEVICE 03/11/1986
K950613 KEISEI (USA) CO., LTD. KEISEI 02/14/1996
K021634 KING SYSTEMS CORP. KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 01/09/2003
K033186 KING SYSTEMS CORP. KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 04/14/2004
K033189 KING SYSTEMS CORP. KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 05/04/2004
K832435 LA SOCIETE FIANCIERE SENEFIN BROOK LIFE SAVING AIRWAY DEVICE #900 & 10/04/1983
K810123 LUOMANEN MEDICAL PRODUCTS THE LUOMANEN ORAL AIRWAY 02/26/1981
K955721 MALLINCKRODT MEDICAL CUFFED OROPHARYNGEAL AIRWAY (COPA) 03/28/1997
K953400 MALLINCKRODT MEDICAL GUEDEL AIRWAY 10/24/1995
K890566 MEDI-SOURCE, INC. BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES 03/15/1989
K880241 MEDIFIELD LTD. 'HILT-WAY' RESUSCITATOR 03/31/1988
K810069 MEDSPEC CORP. STERILE AIRWAY 02/02/1981
K841429 O-TWO SYSTEMS INTL., INC. MOUTH TO MASK EMERGENCY VENTILATION 04/17/1984
K922748 OEM MEDICAL DIV. GUEDEL AIRWAY 07/10/1992
K770001 OMNICON MEDICAL CORP. AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S 01/12/1977
K844873 PENNINE MEDICAL LTD. PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 02/21/1985
K892123 PLASTIC PARTS CORP. GOETTINGER EMERGENCY RESUSCITATION TUBE 07/14/1989
K892053 PROTECTICAL HEALTH & SAFETY LTD. RESPAKIT 04/27/1989
K833328 RESPIRONICS, INC. RESPIRONICS RESCUE DOME 12/16/1983
K842605 RESPIRONICS, INC. RESPIRONICS VENT EASY OXYGEN ENRICHME 07/27/1984
K812822 RIND MEDICAL DEVELOPMENT RIND AIRWAY 11/16/1981
K841120 RSQ INDUSTRIES, INC. RES-Q-MATE 04/05/1984
K960240 RUSCH INTL. RUSCH OPTOSAFE 04/19/1996
K933760 SAVE-T-BREATH DISTRIBUTORS C.C. STB GUEDEL AIRWAY 03/23/1994
K820709 SEVEN HARVEST INTL. IMPORT & EXPORT AIRWAYS 06/25/1982
K936134 SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. BERMAN AIRWAY 01/28/1994
K831078 SURGICAL TECHNOLOGY LABORATORIES, INC. STRAITH ORAL AIRWAY 06/24/1983
K855137 THE KENDAL CO. CURITY FIBEROPTIC INTUBATING AIRWAY 03/11/1986
K130304 THE LARYNGEAL MASK CO.,LTD. LMA FAMILY OF AIRWAYS 05/30/2014
K862199 THE MEDTECH GROUP, INC. MEDTECH C.P.R. MASK 06/13/1986
K874412 TRI JON, INC. THE PROTECTOR 02/12/1988
K820512 VITAL SIGNS, INC. 7CM BERMAN AIRWAY 03/26/1982
K860949 VITALOGRAPH LTD. DUAL-AID 05/06/1986
K871403 WESTMARK ENTERPRISES, INC. MODIFIED C.P.R. MICROSHIELD 05/04/1987
K860780 WESTMARK ENTERPRISES, INC. PLASTIC MOUTH BARRIER HCV-E 04/02/1986
K830767 WILLIAMS AIRWAY INTUBATOR WILLIAMS AIRWAY INTUBATOR 03/31/1983
K833482 WISDOM CORP. WISDOM AIRWAY 12/05/1983


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