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

    INFRARED DELUXE

    K Number: K890586 · Decision Aug 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    8
    Review Days
    197

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    Basic Information

    Device Name
    INFRARED DELUXE
    K Number
    K890586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Healthteam
    Date Received
    February 6, 1989
    Decision Date
    August 22, 1989
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Healthteam

    K Number Device Name
    K890585 INFRARED HEX
    K890588 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
    K852459 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
    K852458 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
    K852457 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
    K852653 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
    K852460 GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY