SEJOY, MODEL MT-403— 510(k) K051699
Substantially EquivalentSejoy Electronics & Instruments Co., Ltd.
FDA 510(k) clearance K051699 for SEJOY, MODEL MT-403, Substantially Equivalent on 2006-02-06. Applicant: Sejoy Electronics & Instruments Co., Ltd..
Clearance details
- Applicant
- Sejoy Electronics & Instruments Co., Ltd.
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.