Home / Device Classification / BYF

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

FDA Device Classification

FDA product code BYF covers "Mask, Oxygen, Low Concentration, Venturi", a Class I medical device regulated under 21 CFR 868.5600. Submissions are reviewed by the Anesthesiology panel. At least 19 recent 510(k) clearances have been granted under this product code.

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

FDA data resources