MODIFICATION TO FLOUROLAB PLUS— 510(k) K013025

Substantially Equivalent

Z-Kat, Inc.

FDA 510(k) clearance K013025 for MODIFICATION TO FLOUROLAB PLUS, Substantially Equivalent on 2001-10-03. Applicant: Z-Kat, Inc..

Clearance details

Applicant: Z-Kat, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2001-09-10
Decision date: 2001-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Hollywood, FL, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.