EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM— 510(k) K113243
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K113243 for EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 2012-03-28. Applicant: Eps Bio Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Eps Bio Technology Corp.
- Product code
- Code LFR
- 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, TW
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More clearances from Eps Bio Technology Corp.
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- K133389 — EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
- K133647 — EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
Adverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
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.