← Product Code [FLK](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK) · K960224

# GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (K960224)

_Rg Ent., Inc. · FLK · Mar 25, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K960224

## Device Facts

- **Applicant:** Rg Ent., Inc.
- **Product Code:** [FLK](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK.md)
- **Decision Date:** Mar 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2920
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K960224](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLK/K960224)

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