EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005— 510(k) K082121
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K082121 for EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005, Substantially Equivalent on 2008-09-17. 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
Recent devices under product code CGA
view allMore clearances from Eps Bio Technology Corp.
view all- K201258 — EASYMAX Tag Self-Monitoring Blood Glucose System
- K190189 — MDT2 BLE Self-Monitoring Blood Glucose System
- K182057 — EasyMax BT Self-Monitoring Blood Glucose System
- K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
- K133389 — EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
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.