EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
FDA 510(k) clearance K083099 · decided 2009-01-16
Clearance details
- K-number
- K083099
- Device name
- EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
- Applicant
- Eps Bio Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-20
- Decision date
- 2009-01-16
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hsinchu City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Eac recall (Z-1937-2009) | Oak Tree International Holdings, LLC, Inc. | 2009-09-10 |