All apps · Heart & circulation

Is McKesson ECG Mobile FDA approved or cleared?

Partly. McKesson ECG Mobile belongs to a product family by McKesson / Change Healthcare that holds a 510(k) clearance, latest decision in 2018, but this exact variant or app is not named in the FDA record.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	McKesson ECG Mobile
Maker	McKesson / Change Healthcare
Care area	Heart & circulation
What it does	Mobile ECG monitoring and analysis platform for healthcare providers
FDA	510(k), latest decision 2018 (product family)
Verification level	Product family authorised; this exact variant or app is not named (checked 18 October 2026)
EU (CE)	No CE listing found
Website	mckesson.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes

Other apps in Heart & circulation

AccurECG FDA verified
Apple Watch Hypertension Notifications FDA verified
Apple Watch/ECG FDA verified
Biocare 12-Lead ECG Machine FDA verified
BPM Pro 2 FDA verified
CADScor®System FDA verified
Cardiacsense FDA verified
CardioFlux FDA verified

All certified heart and blood pressure apps and devices

Search the full directory