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510(k) Data Aggregation
K Number
K203643Device Name
Sensatronic Reusable Temperature Probes
Manufacturer
Date Cleared
2021-08-11
(240 days)
Product Code
Regulation Number
880.2910Why 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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