Monitral S GS Hemodialysis Single Patient Unit
FDA 510(k) K871218 · Hospal Medical Corp.
510(k) numberK871218
Submission
- Device name
- Monitral S GS Hemodialysis Single Patient Unit
- Applicant
- Hospal Medical Corp.
Edison, NJ, US - Received
- March 27, 1987
- Decision date
- April 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Integrated Biomedical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893742 | Filtral TM 20 Hemodialyzer/FilterKDI · Traditional | 07/24/1989SE |
| K884365 | Multiflow(Tm) 60 KitKDI · Traditional | 12/08/1988SE |
| K884326 | Filtral TM 8 HemodialyzerKDI · Traditional | 12/05/1988SE |
| K883307 | Cardioflow 100 Hemoconcentrator/Preparation KitKDI · Traditional | 10/12/1988SE |
| K872767 | Filtral 10, Filtral 12, Filtral 16 HemodialyzerKDI · Traditional | 12/29/1987SE |
| K863961 | Hospal Biospal 1800SKDI · Traditional | 12/17/1986SE |
| K863592 | Disscap 80E, 110E, 140E, 160EFJI · Traditional | 09/25/1986SE |
| K861156 | Hospal Dialysate for CavhdKPO · Traditional | 09/23/1986SE |
| K861230 | Monitral SFKP · Traditional | 04/25/1986SE |
| K854951 | Plume Y SetFIE · Traditional | 01/08/1986SE |
Questions and answers
When was Monitral S GS Hemodialysis Single Patient Unit cleared by the FDA?
Monitral S GS Hemodialysis Single Patient Unit (K871218) received a 510(k) decision of Substantially Equivalent on April 30, 1987, 34 days after the submission was received.
What is the product code of K871218?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.