EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR— 510(k) K043520

Substantially Equivalent

Emg Technology Co., Ltd.

FDA 510(k) clearance K043520 for EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR, Substantially Equivalent on 2005-10-21. Applicant: Emg Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Emg Technology Co., Ltd.
Product code: Code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 2004-12-20
Decision date: 2005-10-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.