HI-LO TEMP ESOPHAGEAL STETHOSCOPE

K811862 · Mallinckrodt Critical Care · BZT · Jul 10, 1981 · Anesthesiology

Device Facts

• Record ID: K811862
• Device Name: HI-LO TEMP ESOPHAGEAL STETHOSCOPE
• Applicant: Mallinckrodt Critical Care
• Product Code: BZT · Anesthesiology
• Decision Date: Jul 10, 1981
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1920
• Device Class: Class 2

Regulatory Classification

Identification

An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.