Class Class II
Withings ECG App (K240795)
Description
Withings ECG App by Withings, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240795
Clearance Date2025-06-15
Clearance TypeTraditional
Product CodeQDA
Regulation Number870.2345
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240795
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Withings ECG App (K240795) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201525 | ECG App | Apple, Inc. | 2020 |
Trace the full predicate network for K240795
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.