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BSJ — Mask, Gas, Anesthetic Class I

FDA Device Classification

Classification Details

Product Code
BSJ
Device Class
Class I
Regulation Number
868.5550
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K163277revolutionary medical devicesSuperNO2VA DeviceOctober 13, 2017
K953107medical marketing conceptsANESTHESIA/RESPIRATORY FACE MASKAugust 15, 1995
K953295mallinckrodt medicalANESTHESIA FACE MASKAugust 11, 1995
K952689owens-brigam medicalBRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKJuly 11, 1995
K951043promedicAIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKJune 7, 1995
K950771advanced warming systemsDISPOSABLE ADHESIVE FACE MASKMarch 10, 1995
K945894hans rudolphMASK, GAS, ANESTHETICJanuary 27, 1995
K945440fvtnksDISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASKNovember 8, 1994
K944157meridian medical systemsDISPOSABLE, PREFORMED FACE MASKOctober 3, 1994
K932147hans rudolphNON CONDUCTIVE ANESTHESIA FACE MASK,SILICONEAugust 20, 1993
K932014ambuAMBU DISPOSABLE FACE MASKJune 22, 1993
K915558iasIAS ANESTHESIA MASKApril 8, 1992
K903881ventlabVENTLAB VENT-MASK, CAT# VR 0010/20/30September 4, 1990
K902298rondex productsORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASAugust 22, 1990
K891316concord/portexANESTHESIA/RESPIRATORY DISPOSABLE MASKAugust 21, 1989
K884157walt productsMODIFIED TOUCH-ME-NOT MASKAugust 21, 1989
K890795respironicsRESPIRONICS SEALEASY IIApril 20, 1989
K890108life design systemsMODIFIED CUSHION-FLEX(TM)January 24, 1989
K884387life design systemsCUSHION FLEX(TM)November 17, 1988
K882434eastmed enterprisesMASK, GAS, ANESTHETICJune 30, 1988