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FDA 510(k)

Ezra Plexo Software

K-Number: K192969 · 2020-07-10

ApplicantEzra Ai, Inc.
Decision Date2020-07-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ezra Plexo Software is the device name listed in this FDA 510(k) record. The listed applicant is Ezra Ai, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K192969. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ezra Plexo Software?

Ezra Plexo Software is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Ezra Ai, Inc.. The 510(k) number is K192969.

When did Ezra Plexo Software receive FDA 510(k) clearance?

Ezra Plexo Software received FDA 510(k) clearance on 2020-07-10, under 510(k) number K192969.

Who is the listed applicant for Ezra Plexo Software?

The FDA 510(k) record lists Ezra Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ezra Plexo Software?

The FDA product code for Ezra Plexo Software is QIH.

Other records listing Ezra Ai, Inc. 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: QIH)

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

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