EAGLE 3000 SDS— 510(k) K912471

Name: FDA 510(k) clearance K912471
Creator: U.S. Food and Drug Administration
Published: 1992-06-26

Substantially Equivalent

Amsco Co.

FDA 510(k) clearance K912471 for EAGLE 3000 SDS, Substantially Equivalent on 1992-06-26. Applicant: Amsco Co.. Device class: 2.

Clearance details

Applicant: Amsco Co.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1991-06-04
Decision date: 1992-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLE

view all

K261055 — AMSCO 700 Steam Sterilizer2026-06-24
K260254 — Enbio PRO2026-02-26
K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
K250164 — Cassette Autoclave (ACA5)2025-08-14

More clearances from Amsco Co.

view all

K854922 — AMSCO POLARIS SL1986-01-24
K833187 — HALL OSTEON1983-10-31
K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA1983-10-19
K831086 — CEILING MOUNTED SUPPORT1983-08-12
K832186 — HALL DRILL/REAMER1983-08-12

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.