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

    DISPOSABLE, PREFORMED FACE MASK

    K Number: K944157 · Decision Oct 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    38

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DISPOSABLE, PREFORMED FACE MASK
    K Number
    K944157
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5550
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Meridian Medical Systems, Inc.
    Date Received
    August 26, 1994
    Decision Date
    October 3, 1994
    Product Code
    BSJ
    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
    BSJ Mask, Gas, Anesthetic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BSJ), ordered by most recent decision date.

    SuperNO2VA Device

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ANESTHESIA/RESPIRATORY FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ANESTHESIA FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DISPOSABLE ADHESIVE FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Meridian Medical Systems, Inc.

    K Number Device Name
    K945984 MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS