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

    OtoSet- Ear Cleaning System

    K Number: K201877 · Decision Nov 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    378
    Registration Numbers
    378
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    121

    Basic Information

    Device Name
    OtoSet- Ear Cleaning System
    K Number
    K201877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SafKan, Inc.
    Date Received
    July 7, 2020
    Decision Date
    November 5, 2020
    Product Code
    KYZ
    Advisory Committee
    General Hospital
    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
    KYZ Syringe, Irrigating (Non Dental)

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