SDW · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2910
Classification
FDA Product Code
SDW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.2910
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.