Continuous Measurement Thermometer

FLL · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2910

Classification

FDA Product Code: FLL
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: Y

Definition

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. 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.

Market data

Cleared 510(k) submissions: 797
Registered establishments: 483

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown