EXTRACORPOREAL TEMPERATURE SENSOR
Device Facts
| Record ID | K935603 |
|---|---|
| Device Name | EXTRACORPOREAL TEMPERATURE SENSOR |
| Applicant | Smiths Industries Medical Systems, Inc. |
| Product Code | FLL · General Hospital |
| Decision Date | Feb 15, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
