GAMBRO WATER PURIFICATION MONITOR WRD— 510(k) K811678

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K811678 for GAMBRO WATER PURIFICATION MONITOR WRD, Substantially Equivalent on 1981-07-10. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1981-06-15
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.