ALPHA OMEGA DUAL COOLER-HEATER— 510(k) K001520

Name: FDA 510(k) clearance K001520
Creator: U.S. Food and Drug Administration
Published: 2000-11-22

Substantially Equivalent

Alpha Omega, Inc.

FDA 510(k) clearance K001520 for ALPHA OMEGA DUAL COOLER-HEATER, Substantially Equivalent on 2000-11-22. Applicant: Alpha Omega, Inc.. Device class: 2.

Clearance details

Applicant: Alpha Omega, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 2000-05-16
Decision date: 2000-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.