← Product Code [FQZ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ) · K771037

# THERMOMETER, SINGLE USE, STRIP, TEMPADOT (K771037)

_Info-Chem · FQZ · Jun 27, 1977 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K771037

## Device Facts

- **Applicant:** Info-Chem
- **Product Code:** [FQZ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ.md)
- **Decision Date:** Jun 27, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2900
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K771037](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FQZ/K771037)

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