510(k) K260242
K260242 is an FDA 510(k) premarket notification submitted by Medibyt , Ltd. for the device "CPETWise Platform". The FDA issued a decision of Substantially Equivalent on August 20, 2026. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2026
- Date Received
- January 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type