LAPEX BCS— 510(k) K081962

Substantially Equivalent

Meridian Co., Ltd.

FDA 510(k) clearance K081962 for LAPEX BCS, Substantially Equivalent on 2008-12-29. Applicant: Meridian Co., Ltd..

Clearance details

Applicant: Meridian Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2008-07-09
Decision date: 2008-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.