Class Class II
BIOMONITOR IV (K230375)
Description
BIOMONITOR IV by Biotronik, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230375
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeMXD
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230375
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. BIOMONITOR IV (K230375) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022 |
Trace the full predicate network for K230375
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.