Product code FQZ
- Device name
- Thermometer, Clinical Color Change
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.2900
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110305 | CRY-ACTRACKERCAM | Brymill Cryogenic Cystems | 2012-01-13 |
| K963049 | STERI-AID KIT | Steri-Aid, Inc. | 1996-11-12 |
| K946046 | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP | Deroyal Critical Care, Div. Deroyal Technologies | 1995-07-19 |
| K894893 | POINT CHECKER COLOR STRIP THERMOMETER | Kyowa Medex Co., Ltd. | 1990-04-05 |
| K884612 | FRANKLIN COLLECTOR(R) | Franklin Diagnostics, Inc. | 1989-03-27 |
| K881286 | TEMPA-DOT CLINICAL THERMOMETER SHEATH | Pymah Corp. | 1988-06-08 |
| K863181 | HEALTHCHECK THERM-STRIP | Healthcheck Corp. | 1986-09-11 |
| K853515 | PEE WEE THERMOMETERS | Joel R.L. Ehren Kranz | 1985-10-16 |
| K822423 | BABY TEMP PACIFIER | Trp Energy Sensors, Inc. | 1982-10-13 |
| K791574 | MODIFIED TEMPA-DOT THERMOMETER | Info-Chem | 1979-09-12 |
| K790890 | TEMPO2-I DISPOSABLE THERMOMETERS | Airlife, Inc. | 1979-06-27 |
| K772233 | THERMOMETER RECAL ADAPTER | Info-Chem | 1977-12-20 |
| K771037 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Info-Chem | 1977-06-27 |
| K771038 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Organon, Inc. | 1977-06-27 |
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| 10889483570883 | AirLife™ | AIRLIFE | 2025-03-27 |
| 10889483570876 | AirLife™ | AIRLIFE | 2025-03-06 |
| 60016944401447 | NexTemp | MEDICAL INDICATORS INC | 2025-02-13 |
| 20016944401425 | NexTemp | MEDICAL INDICATORS INC | 2023-11-17 |
| 10190752157637 | AirLife™ | VYAIRE MEDICAL, INC. | 2022-08-22 |
| 00016944301042 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944401117 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301059 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301066 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301073 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301080 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301134 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301141 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944401025 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944401032 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944401063 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944401100 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301035 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301028 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 00016944301004 | TempaDOT | MEDICAL INDICATORS INC | 2021-05-29 |
| 20016944401043 | NexTemp | MEDICAL INDICATORS INC | 2021-05-29 |
| 08800105200150 | WROOTBOL NOTIPATCH | ONE POWER | 2021-05-17 |
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| 14026704658067 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-05-09 |
| 34026704390145 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-11-07 |
| 34026704595038 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-08-29 |
| 14026704594945 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-08-29 |
| 14026704594938 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-08-29 |
| 10801902135022 | ARROW | TELEFLEX INCORPORATED | 2017-05-27 |