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FDA 510(k)

Revian Lyte (10011)

K-Number: K242441 · 2024-09-13

ApplicantRevian, Inc.
Decision Date2024-09-13
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Revian Lyte (10011) is a medical device manufactured by Revian, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval number K242441. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revian Lyte (10011)?

Revian Lyte (10011) is a medical device that received FDA 510(k) clearance on 2024-09-13. It is manufactured by Revian, Inc.. The 510(k) number is K242441.

When was Revian Lyte (10011) approved by the FDA?

Revian Lyte (10011) received FDA 510(k) clearance on 2024-09-13, under approval number K242441.

What company makes Revian Lyte (10011)?

Revian Lyte (10011) is manufactured by Revian, Inc..

What is the FDA product code for Revian Lyte (10011)?

The FDA product code for Revian Lyte (10011) is OAP.

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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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