Nipro Dry Complete Dry Acid Concentrate for Hemodialysis— 510(k) K193155
Substantially EquivalentNipro Renal Solutions USA, Corp.
FDA 510(k) clearance K193155 for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis, Substantially Equivalent on 2020-11-25. Applicant: Nipro Renal Solutions USA, Corp.. Device class: 2.
Clearance details
- Applicant
- Nipro Renal Solutions USA, Corp.
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewisberry, PA, US
Recent devices under product code KPO
view allMore clearances from Nipro Renal Solutions USA, Corp.
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.