BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.

    K Number: K871101 · Decision Apr 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    31
    Applicant Total
    5
    Review Days
    32

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    Basic Information

    Device Name
    0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
    K Number
    K871101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Matheson Gas Products, Inc.
    Date Received
    March 19, 1987
    Decision Date
    April 20, 1987
    Product Code
    BXK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BXK Gas, Calibration (Specified Concentration)

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    Other Clearances by Matheson Gas Products, Inc.

    K Number Device Name
    K882516 THREE-COMPONENT MEDICAL LASER GAS MIXTURES
    K871100 O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
    K871103 O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
    K871102 O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF