prolaio eVO2peak Module (Version 1.0)— 510(k) K252204
Substantially EquivalentProlaio, Inc.
FDA 510(k) clearance K252204 for prolaio eVO2peak Module (Version 1.0), Substantially Equivalent on 2025-12-16. Applicant: Prolaio, Inc.. Device class: 2.
Clearance details
- Applicant
- Prolaio, Inc.
- Product code
- Code PPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code PPW
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