Thermometer, Clinical Color Change
A clinical color change thermometer is a single-use or reusable temperature measurement device that changes color to indicate body temperature, used in routine patient assessment. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FQZ, regulated under 21 CFR 880.2900, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FQZ
- Device Class
- FDA class 1
- Regulation Number
- 880.2900
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110305 | CRY-ACTRACKERCAM | Jan 13, 2012 | Substantially Equivalent | Brymill Cryogenic Cystems |
| K963049 | STERI-AID KIT | Nov 12, 1996 | Substantially Equivalent | Steri-Aid, Inc. |
| K946046 | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | Jul 19, 1995 | Substantially Equivalent | Deroyal Critical Care, Div. Deroyal Technologies |
| K894893 | POINT CHECKER COLOR STRIP THERMOMETER | Apr 05, 1990 | Substantially Equivalent | Kyowa Medex Co., Ltd. |
| K884612 | FRANKLIN COLLECTOR(R) | Mar 27, 1989 | Substantially Equivalent | Franklin Diagnostics, Inc. |
| K881286 | TEMPA-DOT CLINICAL THERMOMETER SHEATH | Jun 08, 1988 | Substantially Equivalent | Pymah Corp. |
| K863181 | HEALTHCHECK THERM-STRIP | Sep 11, 1986 | Substantially Equivalent | Healthcheck Corp. |
| K853515 | PEE WEE THERMOMETERS | Oct 16, 1985 | Substantially Equivalent | Joel R.L. Ehren Kranz |
| K822423 | BABY TEMP PACIFIER | Oct 13, 1982 | Substantially Equivalent | Trp Energy Sensors, Inc. |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Sep 12, 1979 | Substantially Equivalent | Info-Chem |
| K790890 | TEMPO2-I DISPOSABLE THERMOMETERS | Jun 27, 1979 | Substantially Equivalent | Airlife, Inc. |
| K772233 | THERMOMETER RECAL ADAPTER | Dec 20, 1977 | Substantially Equivalent | Info-Chem |
| K771038 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Jun 27, 1977 | Substantially Equivalent | Organon, Inc. |
| K771037 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Jun 27, 1977 | Substantially Equivalent | Info-Chem |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.