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FDA 510(k)

Cleerly Labs v2.0

K-Number: K202280 · 2020-10-02

ApplicantCleerly, Inc.
Decision Date2020-10-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cleerly Labs v2.0 is a medical device manufactured by Cleerly, Inc.. It received FDA 510(k) clearance on 2020-10-02 under approval number K202280. 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 Cleerly Labs v2.0?

Cleerly Labs v2.0 is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Cleerly, Inc.. The 510(k) number is K202280.

When was Cleerly Labs v2.0 approved by the FDA?

Cleerly Labs v2.0 received FDA 510(k) clearance on 2020-10-02, under approval number K202280.

What company makes Cleerly Labs v2.0?

Cleerly Labs v2.0 is manufactured by Cleerly, Inc..

What is the FDA product code for Cleerly Labs v2.0?

The FDA product code for Cleerly Labs v2.0 is LLZ.

Other Devices by Cleerly, Inc.

K190868Cleerly Labs K231335Cleerly ISCHEMIA K242338Cleerly LABS (v2.0)

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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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