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

    LAB-SITE

    K Number: K905017 · Decision Jan 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    7
    Review Days
    69

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    Basic Information

    Device Name
    LAB-SITE
    K Number
    K905017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telos Medical Corp.
    Date Received
    November 7, 1990
    Decision Date
    January 15, 1991
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Telos Medical Corp.

    K Number Device Name
    K920375 DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
    K920044 DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
    K914387 TRANSCERVICAL INTRAUTERINE KIT
    K905018 LAB-SITE SAFETY NEEDLE
    K882224 ULTRANS DISPOSABLE INTRAUTERINE
    K883832 CATHETER, INTRAUTERINE AND INTRODUCER