THERMOMETER, SINGLE USE, STRIP, TEMPADOT
Device Facts
| Record ID | K771038 |
|---|---|
| Device Name | THERMOMETER, SINGLE USE, STRIP, TEMPADOT |
| Applicant | Organon, Inc. |
| Product Code | FQZ · General Hospital |
| Decision Date | Jun 27, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.
