Esophageal Stethoscope W/Thermocouple Type T

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K864043 ↗

FDA Product Code

BZT

Device Class

Class II

Regulation

21 CFR Part 868.1920

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bi-Temp Temperature Monitor, Model TM-300D

  Class II

  FDA 510(k) K913082 Active Cleared 11 Dec 1991

• Endotracheal Tube Guide or Intubation Stylette

  Class II

  FDA 510(k) K854632 Active Cleared 3 Jan 1986

• Bi-Temp Temperature Monitor, Model Tm-400D

  Class II

  FDA 510(k) K912280 Active Cleared 17 Oct 1991

• Adap-Temp Temperature Sensor Adapter

  Class II

  FDA 510(k) K921190 Active Cleared 9 Mar 1993

• Myocardinal Temperature Sensor with Type 400 Serie

  Class II

  FDA 510(k) K920469 Active Cleared 11 Sep 1992

• Cloud 1 Humidification System

  Class II

  FDA 510(k) K983862 Active Cleared 24 May 1999

See all devices from Respiratory Support Products, Inc. →

• What is the esophageal stethoscope with thermocouple type T used for?

  It is a dual-purpose device designed to monitor heart and respiratory sounds and to measure core body temperature in anesthetized patients during surgical procedures.

• How is the esophageal stethoscope with thermocouple type T supplied?

  It is supplied in various French sizes, including extra-long (22-inch) length options, and is available in regular and soft flexibility variants.

• Is the esophageal stethoscope with thermocouple type T sterile and single-use?

  The device data does not specify sterility or single-use/reuse status; therefore, no implication about sterility or reusability can be made from the provided information.

• What regulatory pathway was used for the esophageal stethoscope with thermocouple type T?

  It received FDA 510(k) clearance (K864043) on December 15, 1986, and is classified under product code BZT for use in anesthesiology.