PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES— 510(k) K122610
Substantially EquivalentSen 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..
Clearance details
- Applicant
- Sen MU Technology Co., Ltd.
- Product code
- Code BYE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kaohsiung City, TW
Adverse events under product code BYE
product code BYE- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.