MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5— 510(k) K024373

Substantially Equivalent

Elltec Co., Ltd.

FDA 510(k) clearance K024373 for MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5, Substantially Equivalent on 2003-01-28. Applicant: Elltec Co., Ltd..

Clearance details

Applicant: Elltec Co., Ltd.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2002-12-31
Decision date: 2003-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Nagoya, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.