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SDW — Stationary Infrared Thermometer Class II

FDA Device Classification

FDA product code SDW covers "Stationary Infrared Thermometer", a Class II medical device regulated under 21 CFR 880.2910. Submissions are reviewed by the General Hospital panel.

Classification Details

Product Code
SDW
Device Class
Class II
Regulation Number
880.2910
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

FDA data resources