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

    DISPOSA-SPEC

    K Number: K840593 · Decision Jul 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    155

    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
    DISPOSA-SPEC
    K Number
    K840593
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Plasti-Products, Inc.
    Date Received
    February 9, 1984
    Decision Date
    July 13, 1984
    Product Code
    ERA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERA Otoscope

    Similar 510(k) Clearances

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

    AIO HD OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LANTOS 3D EAR SCANNER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OSRAM ITOS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OPTUS OTOSCOPES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WELCH ALLYN BI-OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WELCH ALLY OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Plasti-Products, Inc.

    K Number Device Name
    K840595 E-Z OPEN DUST COVERS