DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD— 510(k) K843963
Substantially EquivalentRenal Systems, Inc.
FDA 510(k) clearance K843963 for DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD, Substantially Equivalent on 1985-01-07. Applicant: Renal Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Renal Systems, Inc.
- Product code
- Code FKQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code FKQ
view allMore clearances from Renal Systems, Inc.
view allAdverse events under product code FKQ
product code FKQ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K843963
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K843963.
Data sourced from openFDA. This site is unofficial and independent of the FDA.