Microlife Digital Infrared Ear Thermometer Model IR1DE1-1
by Microlife Intellectual Property GmbH 510(k)
Active
510(k) K034023
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK034023 | Date15 Jan 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 27 Sep 2026
The Microlife Digital Infrared Ear Thermometer Model IR1DE1-1 is a device designed to measure body temperature. It utilizes infrared technology to provide stable, heat-interference-free readings and performs an automatic self-test each time it is switched on to ensure measurement accuracy.
This thermometer has a measuring range of 0 to 100 degrees Celsius and is powered by one CR2032 battery. The device measures 128 by 48 by 30 millimeters and has a gross weight of 52 grams. This product has received FDA 510K authorization.
Other devices from Microlife Intellectual Property GmbH
Questions
AI-generated answers, 27 Sep 2026
How does the Microlife IR1DE1-1 ensure measurement accuracy?
The device is engineered to perform an automatic self-test every time it is switched on. This internal check is designed to ensure the accuracy of the temperature reading before use.
What is the temperature measurement range of this thermometer?
This infrared ear thermometer has a measurement range of 0 to 100 degrees Celsius, allowing it to capture a broad spectrum of temperature readings.
What are the physical dimensions and power requirements for this device?
The thermometer measures 128 by 48 by 30 millimeters and has a gross weight of 52 grams. It is powered by a single CR2032 battery.
What is the regulatory status of the Microlife IR1DE1-1?
This specific model has received FDA 510K authorization, which indicates that it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.