DigiX FDX
K-Number: K162529 · 2017-03-03
ApplicantAllengers Medical Systems Limited
Decision Date2017-03-03
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DigiX FDX is a medical device manufactured by Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2017-03-03 under approval number K162529. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DigiX FDX?
DigiX FDX is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Allengers Medical Systems Limited. The 510(k) number is K162529.
When was DigiX FDX approved by the FDA?
DigiX FDX received FDA 510(k) clearance on 2017-03-03, under approval number K162529.
What company makes DigiX FDX?
DigiX FDX is manufactured by Allengers Medical Systems Limited.
What is the FDA product code for DigiX FDX?
The FDA product code for DigiX FDX is KPR.
Other Devices by Allengers Medical Systems Limited
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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.