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

    TECHNOMED PULSOLITH LASER SYSTEM

    K Number: K895178 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    TECHNOMED PULSOLITH LASER SYSTEM
    K Number
    K895178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Teknomed, Inc.
    Date Received
    August 10, 1989
    Decision Date
    October 6, 1989
    Product Code
    FFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFK Lithotriptor, Electro-Hydraulic

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    Other Clearances by Teknomed, Inc.

    K Number Device Name
    K925395 TECHNOMED PULSOLITH 4000 LASER SYSTEM
    K920708 MULTILASE 2500 A
    K913917 MULTILASE 2100 C, 2100 D
    K913290 MULTILASE 2100 A
    K890436 TECHNOMED PULSOLITH LASER SYSTEM
    K790132 TECNOTOMO