510(k) clearance

CPETWise Platform

FDA 510(k) source

510(k) number

K260242

Applicant

Medibyt , Ltd.

Decision date

Aug 20, 2026

Date received

Jan 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

BTY

Device type

Calculator, Predicted Values, Pulmonary Function

Device class

Class II

Regulation

21 CFR 868.1890

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

Y

Location

Yakum, IL