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

    DOSIMETRIC RELEASE

    K Number: K830546 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    56
    Review Days
    92

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    Basic Information

    Device Name
    DOSIMETRIC RELEASE
    K Number
    K830546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Hospital Supply Corp.
    Date Received
    February 22, 1983
    Decision Date
    May 25, 1983
    Product Code
    KQT
    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
    KQT Evacuator, Gastro-Urology

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    Other Clearances by American Hospital Supply Corp.

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    K822990 CONVERTORS PRIMARY WOUND DRESSING II
    K830343 CONTAINER W/PRIMING SOLUTION
    K830301 STRATUS FLUOROMETRIC ENZYME IMMUN0-
    K822755 LATEX PENROSE TUBING
    K823418 HEYER-SCHUTE UNIVERSAL URETERAL STENT
    K822966 CONVERTORS DISPOSABLE DRESSING SPONGE
    K822754 EAR/ULCER SYRINGE
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