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510(k) Data Aggregation

    K Number
    K030283
    Device Name
    BABY POD
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2003-04-22

    (85 days)

    Product Code
    FPP
    Regulation Number
    880.6900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.
    Device Description
    Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.
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    K Number
    K020447
    Device Name
    MITYVAC MERLIN, MODEL 10027
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2002-04-12

    (60 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.
    Device Description
    The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source.
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    K Number
    K011532
    Device Name
    MITYVAC
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2001-07-30

    (73 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000444
    Device Name
    MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2000-04-21

    (71 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM ENTERPRISES, INC.

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

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