EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2— 510(k) K070053
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K070053 for EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2, Substantially Equivalent on 2007-12-03. Applicant: Eps Bio Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Eps Bio Technology Corp.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu City, TW
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More 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 NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.