Thermometer, Single Use, Strip, Tempadot
FDA 510(k) K771037 · Info-Chem
510(k) numberK771037
Submission
- Device name
- Thermometer, Single Use, Strip, Tempadot
- Applicant
- Info-Chem
Mchenry, IL, US - Received
- June 10, 1977
- Decision date
- June 27, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FQZ – Thermometer, Clinical Color Change
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2900
- Specialty
- General Hospital
Other 510(k)s with product code FQZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110305 | Cry-ActrackercamFQZ · Special | Brymill Cryogenic Cystems | 01/13/2012SE |
| K963049 | Steri-Aid KitFQZ · Traditional | Steri-Aid, Inc. | 11/12/1996SE |
| K946046 | Deroyal Technologices, Inc. Liquid Crystal Skin Temperature StripFQZ · Traditional | Deroyal Critical Care, Div. Deroyal Technologies | 07/19/1995SE |
| K894893 | Point Checker Color Strip ThermometerFQZ · Traditional | Kyowa Medex Co., Ltd. | 04/05/1990SE |
| K884612 | Franklin Collector(R)FQZ · Traditional | Franklin Diagnostics, Inc. | 03/27/1989SE |
| K881286 | Tempa-Dot Clinical Thermometer SheathFQZ · Traditional | Pymah Corp. | 06/08/1988SE |
| K863181 | Healthcheck Therm-StripFQZ · Traditional | Healthcheck Corp. | 09/11/1986SE |
| K853515 | Pee Wee ThermometersFQZ · Traditional | Joel R.L. Ehren Kranz | 10/16/1985SE |
| K822423 | Baby Temp PacifierFQZ · Traditional | Trp Energy Sensors, Inc. | 10/13/1982SE |
| K791574 | Modified Tempa-Dot ThermometerFQZ · Traditional | Info-Chem | 09/12/1979SE |
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Questions and answers
When was Thermometer, Single Use, Strip, Tempadot cleared by the FDA?
Thermometer, Single Use, Strip, Tempadot (K771037) received a 510(k) decision of Substantially Equivalent on June 27, 1977, 17 days after the submission was received.
What is the product code of K771037?
The FDA product code is FQZ – Thermometer, Clinical Color Change, a Class I (low risk) device regulated under 21 CFR 880.2900.