BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE— 510(k) K030348

Substantially Equivalent

Biolab Equipment Canada , Ltd.

FDA 510(k) clearance K030348 for BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE, Substantially Equivalent on 2003-10-21. Applicant: Biolab Equipment Canada , Ltd..

Clearance details

Applicant: Biolab Equipment Canada , Ltd.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-03
Decision date: 2003-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornhill, Ontario, CA

Download summary PDF View on FDA.gov ↗

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.