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BYG — Mask, Oxygen Class I

FDA Device Classification

Classification Details

Product Code
BYG
Device Class
Class I
Regulation Number
868.5580
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K963298vectorFIRST AID KIT(S)November 6, 1996
K962848hans rudolphHANS RUDOLPH NASAL CPAP MASKOctober 16, 1996
K945482fvtnksDISPOSABLE, CPAP OXYGEN MASKSeptember 19, 1995
K953464westmedWESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKSeptember 18, 1995
K953039dadsun corpVARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSSeptember 15, 1995
K945472westmed intlWESTMED PEDIATRIC AND ADULT AEROSOL MASKFebruary 7, 1995
K942907respan productsJEMSDAL MASKAugust 31, 1994
K940887medic-aidSYSTEM 22 ADULT MASKApril 19, 1994
K940888medic-aidSYSTEM 22 PAEDIATRIC MASKApril 19, 1994
K931952medwayMEDWAY OXYGEN MASKAugust 20, 1993
K924069gujarat surgicoSURGICO OXYGEN MASKFebruary 4, 1993
K921499devilbiss health careSEAL RING FOR NASAL CPAPSeptember 17, 1992
K913501b and f medical productsTRACHEOSTOMY MASKJanuary 13, 1992
K913383specialty packaging producsOXYGEN MASKS 81420, 81421, 81471 & 81461October 18, 1991
K913275specialty packaging producsVENTURI OXYGEN MASKOctober 10, 1991
K913455specialty packaging producsOXYGEN MASKS 82400 & 82405October 2, 1991
K912633salter labsSALTER LABS INFANT MEDIUM CONCENTRATION MASKJuly 19, 1991
K905288med-tek innovationsANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZESApril 9, 1991
K904719tri/bor medicalDISPOSABLE FACE MASKJanuary 2, 1991
K904195bpDISPOSABLE FACE MASKSeptember 25, 1990