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Found 6 results

510(k) Data Aggregation

    K Number
    K012263
    Device Name
    MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-10-10

    (84 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000 This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
    Device Description
    Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000
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    K Number
    K012264
    Device Name
    MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-10-10

    (84 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
    Device Description
    Replacement battery for Marquette Mac8, and Mac Stress
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    K Number
    K012259
    Device Name
    MEDFUSION 2001 & 2010, MODEL N7215IWC
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-09-12

    (56 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
    Device Description
    Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP
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    K Number
    K012262
    Device Name
    BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-09-12

    (56 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
    Device Description
    Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP
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    K Number
    K012266
    Device Name
    SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-09-12

    (56 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
    Device Description
    Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH
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    K Number
    K012229
    Device Name
    SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-09-10

    (56 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CUSTOM ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery pack for SCALE-TRONIX MODEL 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 SCALES
    Device Description
    Replacement battery pack
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