CPETWise Platform
Device Facts
| Record ID | K260242 |
|---|---|
| Device Name | CPETWise Platform |
| Applicant | Medibyt , Ltd. |
| Product Code | BTY · Anesthesiology |
| Decision Date | Aug 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1890 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
