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

    GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM

    K Number: K120532 · Decision May 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    7
    Review Days
    435

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    Basic Information

    Device Name
    GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
    K Number
    K120532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge Sourcing, LLC
    Date Received
    February 22, 2012
    Decision Date
    May 2, 2013
    Product Code
    PEC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PEC Sterilizer Automated Loading System

    Other Clearances by Getinge Sourcing, LLC

    K Number Device Name
    K153713 Getinge Series Warming Cabinet
    K122625 GETINGE 800HC- SERIES STEAM STERILIZER
    K122071 GETINGE 400HC-E / SERIES STEAM STERILIZER
    K120441 GETINGE 700HC-E SERIES STEAM STERILIZER
    K103504 GETINGE 400HC/500HC SERIES STEAM STERILIZER
    K070657 GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER