Abreu Model 700
by Brain Tunnelgenix Technologies Corp 510(k)
Active
510(k) K100843
Overview
The Abreu Model 700 is a brain temperature monitoring device designed for continuous measurement of intracranial temperature. Classified under product code FLL, it is intended for use in clinical settings to monitor brain temperature during surgical procedures, recovery, and intensive care environments. Its primary function is to provide real-time thermal data to support patient management and neurological safety protocols.
This device is supplied as a reusable system and is intended for skin-surface placement during surgical and critical care procedures. Authorized under FDA 510(k) clearance (K100843), it was reviewed by the General Hospital Advisory Committee and granted Substantially Equivalent status in August 2010. No specific sterility or MRI safety information is provided in the regulatory data, though its use is restricted to controlled clinical environments where temperature monitoring is clinically indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100843 | Date17 Aug 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
What is the Abreu Model 700 used for?
The Abreu Model 700 is designed for continuous monitoring of intracranial (brain) temperature in clinical settings. It provides real-time thermal data to support patient management during surgical procedures, recovery phases, and intensive care, helping ensure neurological safety by tracking temperature fluctuations critical to brain health.
How is the Abreu Model 700 supplied and intended for use?
This device is supplied as a reusable system and is intended for skin-surface placement. It is specifically engineered for use in controlled clinical environments, such as operating rooms, recovery units, and intensive care units, where precise temperature monitoring is essential for patient care during high-risk procedures.
Is the Abreu Model 700 single-use or reusable?
The Abreu Model 700 is a reusable device. Its design allows for repeated use in clinical settings, provided proper maintenance and cleaning protocols are followed to ensure accuracy and reliability over multiple procedures.
What regulatory approval does the Abreu Model 700 hold?
The Abreu Model 700 holds FDA 510(k) clearance (K100843) and was granted Substantially Equivalent status by the General Hospital Advisory Committee in August 2010. This approval confirms its compliance with U.S. regulatory standards for intracranial temperature monitoring devices.
Are there any specific storage requirements for the Abreu Model 700?
While the regulatory data does not specify detailed storage instructions, the device is intended for use in controlled clinical environments. Proper storage should include protection from physical damage, extreme temperatures, and contamination to maintain its functionality and accuracy for repeated use.