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

    OLYMPIC PASTEURMATIC SYSTEM

    K Number: K953645 · Decision Sep 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    37
    Review Days
    49

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    Basic Information

    Device Name
    OLYMPIC PASTEURMATIC SYSTEM
    K Number
    K953645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6991
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympic Medical Corp.
    Date Received
    August 4, 1995
    Decision Date
    September 22, 1995
    Product Code
    LDS
    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
    LDS Device, Pasteurization, Hot Water

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    Other Clearances by Olympic Medical Corp.

    K Number Device Name
    K081094 OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
    K031149 OLYMPIC CFM 6000
    K020335 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
    K001056 OLYMPIC WARM-UP
    K983229 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
    K971601 OLYMPIC BILI-BASSINET
    K972193 OLYMPIX MINI-PASTEURMATIC (58210)
    K971117 WARMETTE
    K955357 OLYMPIC SMART SCALE MODEL 50/50RA
    K954434 OLYMPIC INFANT THERMOMETER
    Search all 37 clearances from Olympic Medical Corp. →