prolaio eVO2peak Module (Version 1.0)— 510(k) K252204

Substantially Equivalent

Prolaio, Inc.

FDA 510(k) clearance K252204 for prolaio eVO2peak Module (Version 1.0), Substantially Equivalent on 2025-12-16. Applicant: Prolaio, Inc..

Clearance details

Applicant: Prolaio, Inc.
Product code: Code PPW
Advisory panel: Cardiovascular
Date received: 2025-07-14
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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