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FDA 510(k)

Ceevra Reveal 3+

K-Number: K243933 · 2025-03-04

ApplicantCeevra, Inc.
Decision Date2025-03-04
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 2025-03-04 under approval number K243933. 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 2025-03-04. It is manufactured by Ceevra, Inc.. The 510(k) number is K243933.

When was Ceevra Reveal 3+ approved by the FDA?

Ceevra Reveal 3+ received FDA 510(k) clearance on 2025-03-04, under approval number K243933.

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+ K222676Ceevra 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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