NORMOCARB STERILE BICARBONATE RENAL DIALYSIS— 510(k) K001059

Substantially Equivalent

Novex Pharma

FDA 510(k) clearance K001059 for NORMOCARB STERILE BICARBONATE RENAL DIALYSIS, Substantially Equivalent on 2000-06-30. Applicant: Novex Pharma.

Clearance details

Applicant: Novex Pharma
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-03
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond Hill, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.