FDA 510(k)

Ceevra Reveal 2.0

K-Number: K173274 · 2018-07-10

Decision Date2018-07-10

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ceevra Reveal 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ceevra, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K173274. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceevra Reveal 2.0?

Ceevra Reveal 2.0 is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Ceevra, Inc.. The 510(k) number is K173274.

When did Ceevra Reveal 2.0 receive FDA 510(k) clearance?

Ceevra Reveal 2.0 received FDA 510(k) clearance on 2018-07-10, under 510(k) number K173274.

Who is the listed applicant for Ceevra Reveal 2.0?

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

What is the FDA product code for Ceevra Reveal 2.0?

The FDA product code for Ceevra Reveal 2.0 is LLZ.

Other records listing Ceevra, 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.

K243933Ceevra Reveal 3+K233568Ceevra Reveal 3+K222676Ceevra Reveal 3 K171356Clarity Reveal

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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.