GLUCOMANAGER DATA MANAGEMENT SOFTWARE
FDA 510(k) clearance K091229 · decided 2009-07-31
Clearance details
- K-number
- K091229
- Device name
- GLUCOMANAGER DATA MANAGEMENT SOFTWARE
- Applicant
- Eps Bio Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-27
- Decision date
- 2009-07-31
- Days to decision
- 95 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.