Esophageal Thermal Regulation And Gastric Suctioning Device
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.5910
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.