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

    SOFT EAR STETHOSCOPE

    K Number: K870600 · Decision Mar 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    37

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    Basic Information

    Device Name
    SOFT EAR STETHOSCOPE
    K Number
    K870600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5760
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Kalajian Ent.
    Date Received
    February 10, 1987
    Decision Date
    March 19, 1987
    Product Code
    CBG
    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
    CBG Spreader, Cuff

    Other Clearances by Kalajian Ent.

    K Number Device Name
    K884374 E.T. PUFFER
    K883902 INFUSA-PLATE