Tempa-Dot Clinical Thermometer Sheath
FDA 510(k) K881286 · Pymah Corp.
510(k) numberK881286
Submission
- Device name
- Tempa-Dot Clinical Thermometer Sheath
- Applicant
- Pymah Corp.
Somerville, NJ, US - Received
- March 25, 1988
- Decision date
- June 8, 1988
- 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
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| K884612 | Franklin Collector(R)FQZ · Traditional | Franklin Diagnostics, Inc. | 03/27/1989SE |
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| K822423 | Baby Temp PacifierFQZ · Traditional | Trp Energy Sensors, Inc. | 10/13/1982SE |
| K791574 | Modified Tempa-Dot ThermometerFQZ · Traditional | Info-Chem | 09/12/1979SE |
| K790890 | TEMPO2-I Disposable ThermometersFQZ · Traditional | Airlife, Inc. | 06/27/1979SE |
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Questions and answers
When was Tempa-Dot Clinical Thermometer Sheath cleared by the FDA?
Tempa-Dot Clinical Thermometer Sheath (K881286) received a 510(k) decision of Substantially Equivalent on June 8, 1988, 75 days after the submission was received.
What is the product code of K881286?
The FDA product code is FQZ – Thermometer, Clinical Color Change, a Class I (low risk) device regulated under 21 CFR 880.2900.