SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS— 510(k) K863631

Substantially Equivalent

American Healthcare Corp.

FDA 510(k) clearance K863631 for SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS, Substantially Equivalent on 1986-10-16. Applicant: American Healthcare Corp..

Clearance details

Applicant: American Healthcare Corp.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-17
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

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.