Mod. 9542 Flow-Thru Inject. Temp. Sensor
FDA 510(k) K801552 · Edwards Laboratories
510(k) numberK801552
Submission
- Device name
- Mod. 9542 Flow-Thru Inject. Temp. Sensor
- Applicant
- Edwards Laboratories
Mchenry, IL, US - Received
- July 8, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | 01/15/1979SE |
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| K771663 | Probe & CatheterKRB · Traditional | 09/20/1977SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Mod. 9542 Flow-Thru Inject. Temp. Sensor cleared by the FDA?
Mod. 9542 Flow-Thru Inject. Temp. Sensor (K801552) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 20 days after the submission was received.
What is the product code of K801552?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.