CPETWise Platform— 510(k) K260242

Substantially Equivalent

Medibyt , Ltd.

FDA 510(k) clearance K260242 for CPETWise Platform, Substantially Equivalent on 2026-08-20. Applicant: Medibyt , Ltd.. Device class: 2.

Clearance details

Applicant: Medibyt , Ltd.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2026-01-26
Decision date: 2026-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yakum, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTY

K242809 — Ascent Cardiorespiratory Diagnostic Software2024-10-17
K223629 — SpiroSphere, SpiroSphereECG, CardioSphere2024-05-28
K231561 — Pulmonary Function Tester, Model: A92024-02-21
K222982 — Virtus Metabolic Monitor2023-06-23
K221030 — Model 9100 PFT/DICO2022-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.