ESOTEST Esophageal Temperature Probe and Temperature Monitoring System
by Fiab SpA
510(k) K123361
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123361 | Date27 Feb 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ESOTEST Esophageal Temperature Probe and Temperature Monitoring System is a device designed for the continuous detection, measurement, and visualization of esophageal temperature. It consists of a monitor, interconnect cable, and a sterile, single-use esophageal probe containing multiple thermocouple sensors for temperature detection at multiple esophageal points.
The system is intended for use in general hospital settings and is supplied as a sterile, single-use device. It converts analog thermocouple voltages from the probe into digital signals for processing by the monitor, which displays temperature as numerical values, colored bars, and scrolling plots, and includes an integrated alarm system. The device received FDA 510(k) clearance under K123361 and is classified under product code FLL.