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

    PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM

    K Number: K862021 · Decision Jun 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    26

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    Basic Information

    Device Name
    PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
    K Number
    K862021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ultramed, Inc.
    Date Received
    May 28, 1986
    Decision Date
    June 23, 1986
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Ultramed, Inc.

    K Number Device Name
    K882015 TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM
    K873989 DOPPLEX ULTRASONIC DOPPLER SYSTEM
    K861378 ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST
    K850578 PHACOEMULSIFICATION TIP