BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIGITAL MANOMETER (DM 50)

    K Number: K901998 · Decision Jul 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    DIGITAL MANOMETER (DM 50)
    K Number
    K901998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1780
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Support Products, Inc.
    Date Received
    May 2, 1990
    Decision Date
    July 25, 1990
    Product Code
    BXR
    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
    BXR Meter, Airway Pressure (Inspiratory Force)

    Similar 510(k) Clearances

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

    NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS

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    MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER

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    COLLINS DIGITAL PULMONARY MANOMETER

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    THAYER MIP ADAPTER

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    INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING

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