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FDA 510(k)

prolaio eVO2peak Module (Version 1.0)

K-Number: K252204 · 2025-12-16

ApplicantProlaio, Inc.
Decision Date2025-12-16
Product CodePPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

prolaio eVO2peak Module (Version 1.0) is a medical device manufactured by Prolaio, Inc.. It received FDA 510(k) clearance on 2025-12-16 under approval number K252204. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the prolaio eVO2peak Module (Version 1.0)?

prolaio eVO2peak Module (Version 1.0) is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Prolaio, Inc.. The 510(k) number is K252204.

When was prolaio eVO2peak Module (Version 1.0) approved by the FDA?

prolaio eVO2peak Module (Version 1.0) received FDA 510(k) clearance on 2025-12-16, under approval number K252204.

What company makes prolaio eVO2peak Module (Version 1.0)?

prolaio eVO2peak Module (Version 1.0) is manufactured by Prolaio, Inc..

What is the FDA product code for prolaio eVO2peak Module (Version 1.0)?

The FDA product code for prolaio eVO2peak Module (Version 1.0) is PPW.

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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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