HEMODIALYSIS BATH— 510(k) K922990

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K922990 for HEMODIALYSIS BATH, Substantially Equivalent on 1994-09-12. Applicant: Medi-Tech, Inc..

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1992-06-22
Decision date: 1994-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Carmel, TN, 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.