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FDA 510(k)

Ceevra Reveal 3

K-Number: K222676 · 2023-04-25

ApplicantCeevra, Inc.
Decision Date2023-04-25
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ceevra Reveal 3 is a medical device manufactured by Ceevra, Inc.. It received FDA 510(k) clearance on 2023-04-25 under approval number K222676. 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 Ceevra Reveal 3?

Ceevra Reveal 3 is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Ceevra, Inc.. The 510(k) number is K222676.

When was Ceevra Reveal 3 approved by the FDA?

Ceevra Reveal 3 received FDA 510(k) clearance on 2023-04-25, under approval number K222676.

What company makes Ceevra Reveal 3?

Ceevra Reveal 3 is manufactured by Ceevra, Inc..

What is the FDA product code for Ceevra Reveal 3?

The FDA product code for Ceevra Reveal 3 is QIH.

Other Devices by Ceevra, Inc.

K171356Clarity Reveal K173274Ceevra Reveal 2.0 K233568Ceevra Reveal 3+ K243933Ceevra Reveal 3+

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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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