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surface skin temp probe w thermocouple type t
Respiratory Support Products
Summary: The surface skin temperature probe with thermocouple type T is a device used primarily for monitoring skin temperature in clinical settings. It is FDA 510k cleared and linked to studies in various clinical contexts, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K864195 ↗
Decision Date
November 19, 1986
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on November 19, 1986, by Respiratory Support Products. It is classified as a Class 2 device under product code FLL.
What It Is
This device is a surface skin temperature probe utilizing a type T thermocouple to measure skin temperature. It is intended for use in clinical settings to monitor patient temperature during various medical procedures.
Clinical Applications
Commonly used in scenarios requiring precise skin temperature monitoring, such as during ablation procedures or in research settings studying temperature-related physiological responses.
Evidence Summary
The available literature includes five studies, primarily clinical trials registered on ClinicalTrials.gov. These studies explore diverse topics such as exercise-induced hypoalgesia and phototherapy for skin scarring, with no specific focus on the device itself.
Reported Outcomes
Published studies report varied outcomes related to the device's use in different clinical contexts. However, specific efficacy findings directly related to the surface skin temperature probe are not detailed in the provided evidence.
Safety Profile
Reported complications include general safety concerns typical of temperature monitoring devices, though specific adverse events related to this device are not detailed in the provided studies.
Evidence Limitations
The evidence lacks direct studies focusing on the device's efficacy and safety. Further research is needed to establish specific clinical outcomes and potential complications associated with its use.
Frequently Asked Questions
What are the clinical indications for surface skin temp probe w thermocouple type t?
Clinical indications are detailed in the FDA documentation, primarily involving temperature monitoring during medical procedures.
What outcomes have been reported in clinical studies?
Specific outcomes related to the device are not detailed in the provided studies.
What complications have been reported?
The provided evidence does not detail specific complications related to this device.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.