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510(k) Data Aggregation

    K Number
    K972731
    Device Name
    NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1997-09-29

    (69 days)

    Product Code
    KDJ
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLEIN-BAKER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable, manual, peritoneal dialysis administration set for Neonatal patients only.
    Device Description
    Neo-Care Peritoneal Dialysis Adminstration Set
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    K Number
    K970997
    Device Name
    NEO-CARE LUMBER PUNCTURE KIT
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1997-05-22

    (64 days)

    Product Code
    MIA
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLEIN-BAKER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.
    Device Description
    Not Found
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    K Number
    K970434
    Device Name
    NEO-PICC
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1997-04-01

    (55 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLEIN-BAKER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963972
    Device Name
    NEO-CARE DUAL LUMEN UMBILICAL CATHETER
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1996-12-24

    (82 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLEIN-BAKER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963867
    Device Name
    NEO-CARE CATHETERIZATION TRAY
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1996-11-06

    (41 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KLEIN-BAKER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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