EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014— 510(k) K061992
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K061992 for EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014, Substantially Equivalent on 2006-09-19. Applicant: Eps Bio Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Eps Bio Technology Corp.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hsinchu City, TW
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Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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.