21 CFR 880.2910 — Continuous Measurement Thermometer
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2910
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 2 | 797 | 3rd Party |
| OZK | Thermometer, Exhaled Breath | 2 | 0 | |
| PWW | Fever Monitoring Kit | 2 | 0 | |
| PXH | Thermometer Kit | 2 | 0 | |
| SDV | Clinical Electronic Thermometer | 2 | 0 | |
| SDW | Stationary Infrared Thermometer | 2 | 0 |
Special Controls
FLL — Continuous Measurement Thermometer
(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.
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