XPER Technology PREMIUM Pro Blood Glucose Monitoring System
Summary
Taidoc Technology Corporation received 510(k) clearance for XPER Technology PREMIUM Pro Blood Glucose Monitoring System, a PZI device. Cleared on 2024-11-19.
Details
Source
510(k) Clearance
External ID
K221349
Action Date
2024-11-19
Status
Dual Track
Category
device
Product Code
PZI
Product Description
XPER Technology PREMIUM Pro Blood Glucose Monitoring System. Product code: PZI.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Taidoc Technology Corporation has received 3 total clearances in our database.
Taidoc Technology Corporation has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Taidoc Technology Corporation have FDA actions?
Taidoc Technology Corporation has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221349" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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