Duteck Digital Clinical Thermometer
by Duteck Industrial Co., Ltd. 510(k)
Active
510(k) K992327
Overview
The Duteck Digital Clinical Thermometer is a continuous measurement thermometer designed for accurate and rapid temperature assessment in clinical settings. It falls under the category of digital devices used to measure body temperature, providing precise readings for patient monitoring and diagnostic purposes. The device is intended for use in general hospital environments, ensuring reliability in various healthcare applications.
This thermometer is supplied as a single-use or reusable device, depending on clinical protocols, and is regulated under FDA 510(k) clearance (K992327). It features a liquid crystal display (LCD) with a response time of 15 seconds, as documented in regulatory submissions. The device adheres to Class II – Special Controls classification under product code FLL and is intended for use in environments requiring sterile or non-sterile conditions, as determined by facility standards. Storage and handling follow standard clinical thermometer guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992327 | Date18 Aug 1999 | 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- Withdrawn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
Other devices from Duteck Industrial Co., Ltd.
Questions
What is the Duteck Digital Clinical Thermometer used for?
The Duteck Digital Clinical Thermometer is designed for accurate and rapid measurement of body temperature in clinical settings. It supports patient monitoring and diagnostic assessments in general hospital environments, ensuring reliable readings for healthcare applications.
How quickly does the Duteck Digital Clinical Thermometer provide temperature readings?
The device features a liquid crystal display (LCD) with a response time of 15 seconds, delivering fast and precise temperature readings for efficient clinical use.
Is the Duteck Digital Clinical Thermometer single-use or reusable?
The device can be used either as a single-use or reusable option, depending on the clinical protocols and facility standards in place. This flexibility allows healthcare providers to choose based on their infection control and operational needs.
What regulatory approval does the Duteck Digital Clinical Thermometer hold?
The Duteck Digital Clinical Thermometer is regulated under FDA 510(k) clearance with the reference number K992327. It falls under Class II – Special Controls classification, ensuring compliance with stringent safety and performance standards.
How should the Duteck Digital Clinical Thermometer be stored?
Storage follows standard clinical thermometer guidelines. The device should be kept in a clean, dry environment, protected from extreme temperatures, moisture, and physical damage to maintain accuracy and functionality.