Digiscan FDX
K-Number: K200218 · 2020-07-13
ApplicantAllengers Medical Systems Limited
Decision Date2020-07-13
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Digiscan FDX is a medical device manufactured by Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2020-07-13 under approval number K200218. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Digiscan FDX?
Digiscan FDX is a medical device that received FDA 510(k) clearance on 2020-07-13. It is manufactured by Allengers Medical Systems Limited. The 510(k) number is K200218.
When was Digiscan FDX approved by the FDA?
Digiscan FDX received FDA 510(k) clearance on 2020-07-13, under approval number K200218.
What company makes Digiscan FDX?
Digiscan FDX is manufactured by Allengers Medical Systems Limited.
What is the FDA product code for Digiscan FDX?
The FDA product code for Digiscan FDX is OWB.
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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.