Single-Patient Automatic Dialysis Unit Mod. DBB-22
FDA 510(k) K863609 · International Medical Products, Inc.
510(k) numberK863609
Submission
- Device name
- Single-Patient Automatic Dialysis Unit Mod. DBB-22
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- September 16, 1986
- Decision date
- February 25, 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 |
|---|---|---|
| K981003 | Rockwell Medical Supply, LLC Dri-Sate Acid Concentrate MixesKPO · Traditional | 06/16/1998SE |
| K973253 | Rockwell Medical Supply, LLC Concentrate Solutions for Acetate DialysateKPO · Traditional | 10/30/1997SE |
| K971053 | Rockwell Medical Supply,Llc. Bicarbonate Solution Concentrates for Bicarbonate DialysisKPO · Traditional | 06/16/1997SE |
| K920077 | Nikkiso NK PumpDWD · Traditional | 09/29/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | 03/24/1993SE |
| K900755 | Digital Cuff PV GaugeBSK · Traditional | 04/26/1990SE |
| K864984 | RobinjectKZE · Traditional | 06/29/1987SE |
| K861539 | Nikkiso Infusion Pump Model PFA-02FRN · Traditional | 07/31/1986SE |
Questions and answers
When was Single-Patient Automatic Dialysis Unit Mod. DBB-22 cleared by the FDA?
Single-Patient Automatic Dialysis Unit Mod. DBB-22 (K863609) received a 510(k) decision of Substantially Equivalent on February 25, 1987, 162 days after the submission was received.
What is the product code of K863609?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.