FLL · Continuous Measurement Thermometer

General Hospital · 21 CFR 880.2910 · Class 2

Overview

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Classification Rationale

Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Recent Cleared Devices (20 of 797)

Showing 20 most recent of 797 cleared devices.

Top Applicants

• Microlife Intellectual Property GmbH — 20 clearances
• R & D Batteries, Inc. — 19 clearances
• Taidoc Technology Corporation — 16 clearances
• Radiant Innovation, Inc. — 15 clearances
• K-Jump Health Co., Ltd. — 14 clearances