Amplife Digital Clinical Thermometer
by Amplife Corporation 510(k)
Active
510(k) K042575
Overview
The Amplife Digital Clinical Thermometer is a clinical electronic thermometer designed to measure the body temperature of a patient. It functions by utilizing a transducer coupled with an electronic signal amplification, conditioning, and display unit.
This device is identified under FDA 510(k) number K042575. It is classified for use within the general hospital medical specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042575 | Date30 Sep 2004 | 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- Withdrawn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 Amplife Corporation
Questions
What is the primary function of the Amplife Digital Clinical Thermometer?
This device is a clinical electronic thermometer intended to measure a patient's body temperature. It operates by using an internal transducer that captures thermal data, which is then processed through electronic signal amplification and conditioning before being shown on the display unit.
What is the regulatory status of this thermometer?
The Amplife Digital Clinical Thermometer is identified under FDA 510(k) number K042575. It was cleared through the traditional 510(k) process and determined to be substantially equivalent to existing devices within the general hospital medical specialty.
In what medical setting is this device intended to be used?
The device is classified for use within the general hospital medical specialty. It is designed to meet the requirements for clinical temperature monitoring as specified under its product code FLL and advisory committee classification.