2008H ON LINE CLEARANCE MONITOR— 510(k) K961465

Substantially Equivalent

Fresenius USA, Inc.

FDA 510(k) clearance K961465 for 2008H ON LINE CLEARANCE MONITOR, Substantially Equivalent on 1997-07-03. Applicant: Fresenius USA, Inc..

Clearance details

Applicant: Fresenius USA, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-17
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.