DigiX FDX
K-Number: K192541 · 2019-10-16
Device Summary
Frequently Asked Questions
What is the DigiX FDX?
DigiX FDX is a medical device that received FDA 510(k) clearance on 2019-10-16. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K192541.
When did DigiX FDX receive FDA 510(k) clearance?
DigiX FDX received FDA 510(k) clearance on 2019-10-16, under 510(k) number K192541.
Who is the listed applicant for DigiX FDX?
The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DigiX FDX?
The FDA product code for DigiX FDX is KPR.
Other records listing Allengers Medical Systems Limited as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: KPR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.