inforMED
SDWClass II

Stationary Infrared Thermometer

General Hospital · 21 CFR 880.2910

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.

MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time

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Product problems

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Recalls

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Registered firms

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510(k) clearances

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No 510(k) clearances on file for this product code.