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FDA 510(k)

CPETWise Platform

K-Number: K260242 · 2026-08-20

ApplicantMedibyt , Ltd.
Decision Date2026-08-20
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPETWise Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medibyt , Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K260242. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPETWise Platform?

CPETWise Platform is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Medibyt , Ltd.. The 510(k) number is K260242.

When did CPETWise Platform receive FDA 510(k) clearance?

CPETWise Platform received FDA 510(k) clearance on 2026-08-20, under 510(k) number K260242.

Who is the listed applicant for CPETWise Platform?

The FDA 510(k) record lists Medibyt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPETWise Platform?

The FDA product code for CPETWise Platform is BTY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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