EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM— 510(k) K043245
Substantially EquivalentEps Bio Technology Corp.
FDA 510(k) clearance K043245 for EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 2005-04-29. 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
- Traditional
- Location
- Flagstaff, AZ, US
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- 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.