FDA 510(k)

Easyscreen

K-Number: K171506 · 2017-08-29

Decision Date2017-08-29

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Easyscreen is the device name listed in this FDA 510(k) record. The listed applicant is Maico Diagnostics GmbH. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K171506. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Easyscreen?

Easyscreen is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Maico Diagnostics GmbH. The 510(k) number is K171506.

When did Easyscreen receive FDA 510(k) clearance?

Easyscreen received FDA 510(k) clearance on 2017-08-29, under 510(k) number K171506.

Who is the listed applicant for Easyscreen?

The FDA 510(k) record lists Maico Diagnostics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Easyscreen?

The FDA product code for Easyscreen is EWO.

Other records listing Maico Diagnostics GmbH 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.