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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 the device name listed in this FDA 510(k) record. The listed applicant is Revian, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) 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. The listed applicant is Revian, Inc.. The 510(k) number is K242441.

When did Revian Lyte (10011) receive FDA 510(k) clearance?

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

Who is the listed applicant for Revian Lyte (10011)?

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

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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