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

    IV STAND

    K Number: K830474 · Decision Apr 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    18
    Review Days
    49

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    Basic Information

    Device Name
    IV STAND
    K Number
    K830474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Teknar, Inc.
    Date Received
    February 15, 1983
    Decision Date
    April 5, 1983
    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 Teknar, Inc.

    K Number Device Name
    K903666 OPHTHASONIC A/P III
    K896038 B-SCAN 10 MHZ PROBE
    K896150 IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
    K891777 PRO-CUT BIOPSY NEEDLE
    K883965 PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
    K881850 TEKNAR PERCU-SCAN
    K881605 BIOPSY GUIDE
    K880659 TEKNAR PROSCAN ACCESSORY PROBE
    K871536 OPHTHASONIC A-SCAN/ B-SCAN
    K864807 TEKNAR PROSCAN(TM)
    Search all 18 clearances from Teknar, Inc. →