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Updated: Apr 5, 2026

Esophageal Heat Transfer for Patient Temperature Control and Targeted Temperature Management
Published on: November 21, 2017
Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device. Final order
Abstract:
The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Step 1:
Start by practicing proper hand hygiene to prevent the spread of microorganisms.
Step 2:
Take the thermometer out of the charging unit, switch it on, and wait for the ready sign.
Step 3:
Gently slide the probe cover until a click is heard. This simple action prevents cross-contamination and ensures the correct placement of the probe cover.
Step 4:
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