PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES— 510(k) K122610

Name: FDA 510(k) clearance K122610
Creator: U.S. Food and Drug Administration
Published: 2013-08-05

Substantially Equivalent

Sen MU Technology Co., Ltd.

FDA 510(k) clearance K122610 for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES, Substantially Equivalent on 2013-08-05. Applicant: Sen MU Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sen MU Technology Co., Ltd.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 2012-08-27
Decision date: 2013-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.