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

    ADEL - MODEL 986 INFANT WARMER

    K Number: K890476 · Decision Jun 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    8
    Review Days
    136

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    Basic Information

    Device Name
    ADEL - MODEL 986 INFANT WARMER
    K Number
    K890476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Adel Medical , Ltd.
    Date Received
    January 31, 1989
    Decision Date
    June 16, 1989
    Product Code
    FMZ
    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
    FMZ Incubator, Neonatal

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    Other Clearances by Adel Medical , Ltd.

    K Number Device Name
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    K861030 LABOR-DELIVERY STRETCH/BED
    K860020 MINOR SURGERY LIGHT MODEL 2112
    K833321 LABOR/DELIVERY/RECOVERY BED LDR-600
    K810886 ADEL MEDICAL BIRTHING BED, #LD-500
    K801622 ADEL MEDICAL BIRTHING BED, MOD. LD-400