VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Summary
Vinno Technology (Suzhou) Co.,Ltd received 510(k) clearance for VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P, a IYN device. Cleared on 2023-06-17.
Details
Source
510(k) Clearance
External ID
K223917
Action Date
2023-06-17
Status
Traditional
Category
device
Product Code
IYN
Product Description
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P. Product code: IYN.
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. Vinno Technology (Suzhou) Co.,Ltd has received 5 total clearances in our database.
Vinno Technology (Suzhou) Co.,Ltd has 5 FDA actions in our database, including 5 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 Vinno Technology (Suzhou) Co.,Ltd have FDA actions?
Vinno Technology (Suzhou) Co.,Ltd has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223917" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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