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

    EAR PROBES

    K Number: K822568 · Decision Sep 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    94
    Review Days
    21

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    Basic Information

    Device Name
    EAR PROBES
    K Number
    K822568
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3840
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Kelleher Corp.
    Date Received
    August 24, 1982
    Decision Date
    September 14, 1982
    Product Code
    EKL
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EKL Point, Silver, Endodontic

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    K822252 ENT TREATMENT UNITS
    K822272 HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS
    K822017 TYMPANOSTOMY TUBES & VARIOUS TYPES
    K822257 VARIOUS TYPES OF LIGHT SOURCE HANDLES
    K822259 LARYNGEAL SPATULAS
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