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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2020-07-13 under 510(k) 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. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K200218.

When did Digiscan FDX receive FDA 510(k) clearance?

Digiscan FDX received FDA 510(k) clearance on 2020-07-13, under 510(k) number K200218.

Who is the listed applicant for Digiscan 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 Digiscan FDX?

The FDA product code for Digiscan FDX is OWB.

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.

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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.

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