FQZ · Thermometer, Clinical Color Change
General Hospital · 21 CFR 880.2900 · Class 1
Overview
| Product Code | FQZ |
|---|---|
| Device Name | Thermometer, Clinical Color Change |
| Regulation | 21 CFR 880.2900 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110305 | CRY-ACTRACKERCAM | Brymill Cryogenic Cystems | Jan 13, 2012 | SESE |
| K963049 | STERI-AID KIT | Steri-Aid, Inc. | Nov 12, 1996 | SESE |
| K946046 | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | Deroyal Critical Care, Div. Deroyal Technologies | Jul 19, 1995 | SESE |
| K894893 | POINT CHECKER COLOR STRIP THERMOMETER | Kyowa Medex Co., Ltd. | Apr 5, 1990 | SESE |
| K884612 | FRANKLIN COLLECTOR(R) | Franklin Diagnostics, Inc. | Mar 27, 1989 | SESE |
| K881286 | TEMPA-DOT CLINICAL THERMOMETER SHEATH | Pymah Corp. | Jun 8, 1988 | SESE |
| K863181 | HEALTHCHECK THERM-STRIP | Healthcheck Corp. | Sep 11, 1986 | SESE |
| K853515 | PEE WEE THERMOMETERS | Joel R.L. Ehren Kranz | Oct 16, 1985 | SESE |
| K822423 | BABY TEMP PACIFIER | Trp Energy Sensors, Inc. | Oct 13, 1982 | SESE |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Info-Chem | Sep 12, 1979 | SESE |
| K790890 | TEMPO2-I DISPOSABLE THERMOMETERS | Airlife, Inc. | Jun 27, 1979 | SESE |
| K772233 | THERMOMETER RECAL ADAPTER | Info-Chem | Dec 20, 1977 | SESE |
| K771038 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Organon, Inc. | Jun 27, 1977 | SESE |
| K771037 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Info-Chem | Jun 27, 1977 | SESE |
Top Applicants
- Info-Chem — 3 clearances
- Airlife, Inc. — 1 clearance
- Brymill Cryogenic Cystems — 1 clearance
- Deroyal Critical Care, Div. Deroyal Technologies — 1 clearance
- Franklin Diagnostics, Inc. — 1 clearance
