Product code SDW
- Device name
- Stationary Infrared Thermometer
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2910
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a persons 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.
- Source
- FDA openFDA device classification dataset