Class Class II
HiCardi+ H100 (K232670)
Description
HiCardi+ H100 by Mezoo Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK232670
Clearance Date2024-09-20
Clearance TypeTraditional
Product CodeDSH
Regulation Number870.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K232670
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. HiCardi+ H100 (K232670) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 |
Trace the full predicate network for K232670
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.