| Device |
stationary infrared thermometer |
| Regulation Description |
Clinical electronic thermometer. |
| Definition |
A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a person’s body temperature. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf. |
| Physical State |
The device may be a stand-alone device or mounted onto a surface such as a desk, a wall, or a wheeled cart. The stationary infrared thermometer may include a camera and display to show an image of the person during temperature measurements. |
| Technical Method |
The device is a free-standing or mounted, non-contact infrared thermometer that uses a thermal infrared sensor to measure a person’s body temperature. |
| Target Area |
External body surfaces. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SDW |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.2910
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
