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510(k) Data Aggregation

    K Number
    K973850
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-11-12

    (35 days)

    Product Code
    HFO
    Regulation Number
    884.2700
    Why did this record match?
    Product Code :

    HFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number M007
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