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SDWClass II

Stationary Infrared Thermometer

21 CFR 880.2910 / General Hospital
FDA source (opens on fda.gov)

SDW is the FDA product code for Stationary Infrared Thermometer, a class II device type, regulated under 21 CFR 880.2910. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SDW
Device name
Stationary Infrared Thermometer
FDA 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.
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SDW.