MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES— 510(k) K100920

Substantially Equivalent

Sequal Technologies Co., Ltd.

FDA 510(k) clearance K100920 for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES, Substantially Equivalent on 2010-11-29. Applicant: Sequal Technologies Co., Ltd..

Clearance details

Applicant: Sequal Technologies Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2010-04-02
Decision date: 2010-11-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taipei, TW

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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.