K260242
- 510(k) number
- K260242
- Device name
- CPETWise Platform
- Applicant
- Medibyt , Ltd. IL
- Product code
- BTY — Calculator, Predicted Values, Pulmonary Function
- Decision date
- 2026-08-20
- Date received
- 2026-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K260242.pdf
Official FDA record: K260242
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.