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510(k) Data Aggregation

    K Number
    K203643
    Device Name
    Sensatronic Reusable Temperature Probes
    Manufacturer
    Date Cleared
    2021-08-11

    (240 days)

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

    Sensatronic GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes. The probes are indicated for use by qualified medical personnel only. Prescription use only.
    Device Description
    Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification. Sensatronic Reusable Temperature Probes are constructed with the following features: - . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization - . Two internal conductors for connection to the thermistor - . Internal Kevlar fibers for strength and pull resistance - Biocompatible outer jacket of thermoplastic rubber (TPR) - . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below) - The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm - 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems.
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