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

    ACCESS (POWERCLAVE)

    K Number: K954736 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    8
    Review Days
    304

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    Basic Information

    Device Name
    ACCESS (POWERCLAVE)
    K Number
    K954736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mdt Biologic Co.
    Date Received
    October 16, 1995
    Decision Date
    August 15, 1996
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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    Other Clearances by Mdt Biologic Co.

    K Number Device Name
    K954940 MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
    K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    K911087 CASTLE WASHER/DISINFECTOR, MODEL 7550
    K910777 MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
    K910778 STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
    K910649 MDT/CASTLE 10/90 LOAD STATION
    K910942 AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT