Class Class II
BB-613-BPM (K241066)
Description
BB-613-BPM by Biobeat Technologies , Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241066
Clearance Date2025-01-14
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241066
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. BB-613-BPM (K241066) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022 |
| K190792 | BB-613WP | Biobeat Technologies , Ltd. | 2019 |
Trace the full predicate network for K241066
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.