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BYF — Mask, Oxygen, Low Concentration, Venturi Class I

FDA Device Classification

Classification Details

Product Code
BYF
Device Class
Class I
Regulation Number
868.5600
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K955483hospitakTRACH MASK MODEL (245, 246)February 28, 1996
K951652flexicare medicalVENTIMASK MK IVApril 27, 1995
K894457dadsun corpCARNATION TRACHEOSTOMY MASKSOctober 13, 1989
K860873dhd medical products div. diemoldingVENTURI MASK/ADULT & PAEDIATRICMarch 20, 1986
K860874dhd medical products div. diemoldingVENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICMarch 19, 1986
K852618ashai co.OXY-DIALSeptember 18, 1985
K832725airlifeDUAL DIAL VENTURI STYLE MASKSeptember 20, 1983
K812066airlifePERCENTO MASK, PEDIATRIC, UNDER-THE-CHINAugust 3, 1981
K810947airlifeAIR ENTRAINMENT TRACH TJune 2, 1981
K810946airlifeADULT & PEDIATRIC TRACHEOSTOMY MASKSJune 2, 1981
K810373todd industriesVENTURI MASK/DELIVERY SYSTEM #'SMarch 17, 1981
K810430todd industriesVENTURI MASK/DELIVERY SYSTEM #6078March 13, 1981
K790146airlifeMASK, PERCENTOFebruary 6, 1979
K781325vickers america medicalMARKII VENTIMASKSSeptember 27, 1978
K780626hospitakVENTURI OXYGEN MASKMay 26, 1978
K780011respiratory careCONCHAPAK OXYGEN DILUTERFebruary 2, 1978
K772127salter labsOXYGEN MASK, AIR-ENTRAINMENTJanuary 3, 1978
K771385bd becton dickinson vacutainer systems preanalytic2 JET SETAugust 4, 1977
K760518landmark plasticsADAPTER, PER-CEN-TOX-BODYSeptember 3, 1976