FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES— 510(k) K070177
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K070177 for FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES, Substantially Equivalent on 2007-03-29. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code KPO
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Adverse 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.