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510(k) Data Aggregation

    K Number
    K032315
    Device Name
    IOP8 INTRA OPERATIVE PROBE
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2004-11-18

    (479 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 10P8 is a passive, self contained, sterilizable, reusable, Pulsed Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting. The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.
    Device Description
    The IOP8 consists of a small diameter stainless steel tube and an interconnection cable. The tube houses a PZT crystal that is protected by a faceplate. A cable links the IOP8 probe tube to an interconnection adapter (designated PA8) that houses the bi-directional electronics. This adapter in turn connects to a main Doppler unit, which is required to drive the IOP8 / PA8 system. A connector system at the end of the cable allows the IOP8 to be removed and externally sterilized before use. The interconnection adapter and main Doppler unit(s) are not sterilizable, and remain outside the sterile field.
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    K Number
    K022786
    Device Name
    DVT60
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2002-09-19

    (28 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
    Device Description
    The DVT60 Compression Sleeves are single chamber inflatable cuffs, designed to fit around a patient's calf. They are used with the Huntleigh Flowtron Excel and Universal Pumps. When inflated, they compress the veins in the calf and expel blood out of the leg, promoting circulation and overcoming stasis.
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    K Number
    K010744
    Device Name
    FLOWTRON UNIVERSAL, MODEL AC600
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2002-03-26

    (378 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K012008
    Device Name
    STS RANGE , MODELS STS20,STS30,STS40
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2001-09-21

    (86 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
    Device Description
    The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.
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    K Number
    K002186
    Device Name
    VASCULAR ASSIST
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2001-05-02

    (286 days)

    Product Code
    DPW, JAF, JOM
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010889
    Device Name
    BABY DOPPLEX 3000 MK 2 (BD3000)
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2001-04-25

    (30 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010894
    Device Name
    BABY DOPPLEX 3002 (BD3002)
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2001-04-25

    (30 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001882
    Device Name
    BABY DOPPLEX 4002-TWINS, MODEL BD4002
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2000-09-19

    (90 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990569
    Device Name
    BABY DOPPLEX 4000, MODEL BD 4000
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    2000-01-24

    (335 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations. In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.
    Device Description
    The BD4000 is a fetal monitor, which produces cardiotocographs (CTG) and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the BD4000 main unit allows it to perform Intrapartum monitoring operations. In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously. The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards. Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1. A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC. Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1.
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    K Number
    K984307
    Device Name
    MODIFICATION OF: RHEO DOPPLEX II
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Date Cleared
    1999-01-12

    (41 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Venous photoplethysmography and bi-directional Doppler for venous and arterial vonous protoproxity and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.
    Device Description
    Not Found
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