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

    DISP. TRANSDUCER DOMES TD200 & TD300

    K Number: K802069 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    DISP. TRANSDUCER DOMES TD200 & TD300
    K Number
    K802069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Med Corp.
    Date Received
    August 27, 1980
    Decision Date
    September 9, 1980
    Product Code
    DRS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by Bio-Med Corp.

    K Number Device Name
    K823286 MODELS DPT 1000/DPT 1000NS
    K810735 DISPOSABLE, STERILE TRANSDUCER DOMES
    K802092 HF-100 DIALYZER
    K801985 BIO-MED CORP. DISP. NON-STERILE TRANSDU