ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE— 510(k) K973253

Substantially Equivalent

International Medical Products, Inc.

FDA 510(k) clearance K973253 for ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE, Substantially Equivalent on 1997-10-30. Applicant: International Medical Products, Inc..

Clearance details

Applicant: International Medical Products, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1997-08-29
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.