510(k) K993877— NELSON WATER SYSTEMS FOR HEMODIALYSIS

Substantially Equivalent

Nelson Environmental Technologies, Inc.

Clearance details

Applicant: Nelson Environmental Technologies, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1999-11-15
Decision date: 2000-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcallen, 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.