SDW

Stationary Infrared Thermometer

Product code: SDW
Device name: Stationary Infrared Thermometer
Device class: Class 2
21 CFR: 21 CFR 880.2910
Medical specialty: General Hospital
Marketing pathway: 510(K)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SDW

Classification and pathway per current FDA publications. Data from openFDA (CC0).