Model 90 Pressure/Conductivity/Temp Test
FDA 510(k) K801303 · Western Laboratories Corp.
510(k) numberK801303
Submission
- Device name
- Model 90 Pressure/Conductivity/Temp Test
- Applicant
- Western Laboratories Corp.
Mchenry, IL, US - Received
- June 3, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K834024 | HeparinometerKFF · Traditional | 06/11/1984SE |
| K830468 | Model 200FTZ · Traditional | 04/12/1983SE |
| K821834 | Model 100 Bicarbonate ConductivityFKQ · Traditional | 07/02/1982SE |
| K821415 | Model 90 BCFLB · Traditional | 05/27/1982SE |
| K821414 | Model 80 BC · Traditional | 05/27/1982SE |
| K780932 | Model 80 Conductivity/Temp.Test UnitFIZ · Traditional | 08/31/1978SE |
Questions and answers
When was Model 90 Pressure/Conductivity/Temp Test cleared by the FDA?
Model 90 Pressure/Conductivity/Temp Test (K801303) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 55 days after the submission was received.
What is the product code of K801303?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.