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

    HR-3000 REUSE ADAPTOR

    K Number: K870689 · Decision Apr 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    50

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HR-3000 REUSE ADAPTOR
    K Number
    K870689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Colorado Medical, Inc.
    Date Received
    February 19, 1987
    Decision Date
    April 10, 1987
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LIF), ordered by most recent decision date.

    CLEARFLUX DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASSIST HEADER CLEANER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STERICHEK GLUTARALDEHYDE REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RENACLEAN SH DIALYZER CLEANING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MAKY 21.1 DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARM AUTOMATIC REPROCESSING MACHINE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Colorado Medical, Inc.

    K Number Device Name
    K870471 MODIFIED HR-3000 REUSE ADAPTOR
    K863471 COLORADO MEDICAL MODEL PTC 1000
    K853735 COLORADO MEDICAL MODEL CTM-3000
    K841153 ADAPTOR HR-3000 REUSE
    K830190 AHR-3000 RE-USE ADAPTOR