FQZ — Thermometer, Clinical Color Change Class I
FDA product code FQZ covers "Thermometer, Clinical Color Change", a Class I medical device regulated under 21 CFR 880.2900. Submissions are reviewed by the General Hospital panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FQZ
- Device Class
- Class I
- Regulation Number
- 880.2900
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110305 | Brymill Cryogenic Cystems | CRY-ACTRACKERCAM | Jan 13, 2012 |
| K963049 | Steri-Aid | STERI-AID KIT | Nov 12, 1996 |
| K946046 | Deroyal Critical Care, Div. Deroyal Technologies | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | Jul 19, 1995 |
| K894893 | Kyowa Medex Co | POINT CHECKER COLOR STRIP THERMOMETER | Apr 5, 1990 |
| K884612 | Franklin Diagnostics | FRANKLIN COLLECTOR(R) | Mar 27, 1989 |
| K881286 | Pymah | TEMPA-DOT CLINICAL THERMOMETER SHEATH | Jun 8, 1988 |
| K863181 | Healthcheck | HEALTHCHECK THERM-STRIP | Sep 11, 1986 |
| K853515 | Joel R.L. Ehren Kranz | PEE WEE THERMOMETERS | Oct 16, 1985 |
| K822423 | Trp Energy Sensors | BABY TEMP PACIFIER | Oct 13, 1982 |
| K791574 | Info-Chem | MODIFIED TEMPA-DOT THERMOMETER | Sep 12, 1979 |
| K790890 | Airlife | TEMPO2-I DISPOSABLE THERMOMETERS | Jun 27, 1979 |
| K772233 | Info-Chem | THERMOMETER RECAL ADAPTER | Dec 20, 1977 |
| K771038 | Organon | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Jun 27, 1977 |
| K771037 | Info-Chem | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Jun 27, 1977 |