Class Class II
ZBPro Diagnostic (K243252)
Description
ZBPro Diagnostic by Zbeats, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243252
Clearance Date2025-07-10
Clearance TypeTraditional
Product CodeDPS
Regulation Number870.2340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243252
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. ZBPro Diagnostic (K243252) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021 |
Trace the full predicate network for K243252
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.