DETECT— 510(k) K121206

Substantially Equivalent

Forum Engineering Technologies, Ltd.

FDA 510(k) clearance K121206 for DETECT, Substantially Equivalent on 2013-01-10. Applicant: Forum Engineering Technologies, Ltd..

Clearance details

Applicant: Forum Engineering Technologies, Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2012-04-20
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rishon Lezion, IL

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.