Identifiers
- 510(k) Number
- K092716 FDA 510(k)
- FDA Product Code
- BZT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1920 FDA 510(k)
- Regulation Number
- 868.1920 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Esophageal Stethoscope is a device with electrical conductors designed for monitoring the heart and lung sounds of anesthetized patients. It is inserted into the esophagus to provide an accurate measurement of core body temperature while simultaneously transmitting acoustic data.
This device is intended for use in a surgical setting and is supplied as a disposable product. It has received FDA 510k clearance under the anesthesiology medical specialty.
Frequently asked questions
What is the primary function of the Esophageal Stethoscope?
This device is designed for use in surgical settings to monitor the heart and lung sounds of anesthetized patients. It also functions to provide an accurate measurement of core body temperature during the procedure.
Is this device intended for single-use or reuse?
The Esophageal Stethoscope is supplied as a disposable product. This design ensures that each patient receives a sterile, single-use device, which helps maintain hygiene standards in the surgical environment.
What is the regulatory status of this device?
The Esophageal Stethoscope manufactured by Truer Medical, Inc. has received FDA 510k clearance under the anesthesiology medical specialty, identified by K-number K092716.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Esophageal Stethoscopes - Truer Medical, Esophageal Stethoscopes | Truer Medical, Esophageal Stethoscopes - Tri-anim
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092716 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Truer Medical, Inc.
Sources (1)
- FDA 510(k) K092716 24 fields · synced Sep 22, 2026