DigiX FDX
Summary
Allengers Medical Systems Limited received 510(k) clearance for DigiX FDX, a KPR device. Cleared on 2022-10-26.
Details
Source
510(k) Clearance
External ID
K223060
Action Date
2022-10-26
Status
Special
Category
device
Product Code
KPR
Product Description
DigiX FDX. Product code: KPR.
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. Allengers Medical Systems Limited has received 5 total clearances in our database.
Allengers Medical Systems Limited 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 Allengers Medical Systems Limited have FDA actions?
Allengers Medical Systems Limited 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 "K223060" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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