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

Name: FDA 510(k) clearance K024373
Creator: U.S. Food and Drug Administration
Published: 2003-01-28

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.. Device class: 2.

Clearance details

Applicant: Elltec Co., Ltd.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
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 ↗

Recent devices under product code LGZ

view all

K260988 — °M Warmer System with °M Station2026-04-24
K252636 — Fluido Compact System2025-11-18
K251733 — Fluido® AirGuard System2025-09-04
K232107 — °M Warmer System2024-05-31
K211618 — Fluido Compact Blood and Fluid Warming System2023-06-05

More clearances from Elltec Co., Ltd.

view all

K012906 — ANIMEC, MODELS AM-2S-4 AND AM-2S-52001-10-09

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.