TruTek Select Model TT-1001
by Trutek Corp 510(k)
Active
510(k) K023510
Overview
The TruTek Select Model TT-1001 is an electronic clinical thermometer that utilizes infrared sensor technology to measure body temperature from the auditory canal. It is designed for use by medical professionals in clinical settings for both adult and pediatric patients. The device captures infrared radiation emitted from the ear canal and converts the signal into a digital temperature reading.
The TruTek Select Model TT-1001 is supplied as a Class 2 device with FDA 510(k) clearance K023510, received on 2002-10-21 and decided as substantially equivalent on 2003-02-04. It is regulated under product code FLL and intended for use in general hospital settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023510 | Date4 Feb 2003 | 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- Withdrawn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
- FDA applicant
- Trutek, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trutek Corp
Questions
What is the TruTek Select Model TT-1001 used for?
The TruTek Select Model TT-1001 is an electronic clinical thermometer designed for medical professionals to measure body temperature from the auditory canal of both adult and pediatric patients in clinical settings.
How is the TruTek Select Model TT-1001 supplied?
The device is supplied as a Class 2 medical device with FDA 510(k) clearance K023510, received on October 21, 2002, and determined to be substantially equivalent on February 4, 2003.
Is the TruTek Select Model TT-1001 single-use or reusable?
The device is not specified as single-use or reusable in the provided information. Users should refer to the manufacturer's instructions for proper handling and reuse guidelines.
What are the regulatory specifications for the TruTek Select Model TT-1001?
The TruTek Select Model TT-1001 is regulated under product code FLL and intended for use in general hospital settings. It received FDA 510(k) clearance with the determination of substantial equivalence.