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

FDA 510(k) Number Applicant Device Name Decision Date
K950613 KEISEI (USA) CO., LTD. KEISEI 02/14/1996
K033186 KING SYSTEMS CORP. KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 04/14/2004
K021634 KING SYSTEMS CORP. KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 01/09/2003
K033189 KING SYSTEMS CORP. KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 05/04/2004
K955721 MALLINCKRODT MEDICAL CUFFED OROPHARYNGEAL AIRWAY (COPA) 03/28/1997
K960240 RUSCH INTL. RUSCH OPTOSAFE 04/19/1996
K130304 THE LARYNGEAL MASK CO.,LTD. LMA FAMILY OF AIRWAYS 05/30/2014


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