K014169

Substantially Equivalent

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

Applicant: Bob J. Johnson & Assoc., Inc.
Product code: FIP
Advisory panel: Gastroenterology, Urology
Date received: 2001-12-19
Decision date: 2002-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio,, TX, US

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.