K221349
- 510(k) number
- K221349
- Device name
- XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- Applicant
- Taidoc Technology Corporation TW
- Product code
- PZI — Prescription Use Blood Glucose Meter For Near-Patien
- Decision date
- 2024-11-19
- Date received
- 2022-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K221349.pdf
Official FDA record: K221349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.