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510(k) Data Aggregation

    K Number
    K242964
    Device Name
    Celsi Warmer
    Manufacturer
    Hadleigh Health Technologies
    Date Cleared
    2025-06-20

    (267 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hadleigh Health Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates. a. Maintain pre-set body temperature as determined by the physician. b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. c. Monitoring and controlling patient temperature.
    Device Description
    The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components: - Warming Mattress - Controller Tower - Celsi Temperature Probe and Celsi Belt - Power Supply and Cables
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    K Number
    K230298
    Device Name
    Celsi Monitor
    Manufacturer
    Hadleigh Health Technologies
    Date Cleared
    2023-08-16

    (195 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hadleigh Health Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Celsi Monitor is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device abdominal skin temperature through direct contact.
    Device Description
    Celsi Monitor is a non-invasive continuous temperature monitor. Celsi Monitor achieves its intended purpose by measuring temperature at the surface of a neonate's abdomen by sensing changes in electrical resistance of a thermistor that is in thermal contact with the skin at the measured point. Celsi Monitor is provided with the Celsi Belt. The Celsi Monitor is powered by two rechargeable lithium-ion batteries. Both the Celsi Belt and Celsi Probe are reusable. The device displays measured patient body temperature for up to 12 hours and alarms when the temperature falls outside normothermic levels (<36.5 or >37.5 °C). The device is a skin contacting surface device with duration of contact < 24 hours.
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    K Number
    K181034
    Device Name
    Pocket Colposcope System
    Manufacturer
    Hadleigh Health Technologies, LLC
    Date Cleared
    2018-09-21

    (156 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hadleigh Health Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
    Device Description
    The Pocket Colposcope is a reusable, high-definition video colposcope intended to be used in a hospital / clinical environment for examination of the tissues of the vagina, cervix and external female genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The Pocket Colposcope can be used outside of the body to capture images of the vagina and external genitalia or can be inserted through a vaginal speculum to capture images of the cervix and surrounding tissue. The Pocket Colposcope it is not intended to come into direct contact with the body. The Pocket Colposcope utilizes a ring or single loop of LED lights to illuminate the target tissue. The digital color image generated by the Pocket Colposcope is intended to be used to aid in diagnosing abnormalities and selecting areas for biopsy. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances. The Pocket Colposcope has a 5 MP CMOS camera with a 0° angled lens. The Pocket Colposcope uses a computer-based software program to display the camera output on a computer screen and to capture images. Together, the Pocket Colposcope and the software comprise the Pocket Colposcope System.
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