EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM— 510(k) K111728
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K111728 for EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 2011-09-16. 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, 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.