B4C System – Addition of new sensor model (BcSs-PICNIW-2000) (K240821)
Description
B4C System - Addition of new sensor model (BcSs-PICNIW-2000) by Braincare Desenvolvimento E Inovação Tecnológica S.A., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240821
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. B4C System – Addition of new sensor model (BcSs-PICNIW-2000) (K240821) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201989 | B4C System | Braincare Desenvolvimento E Inovaca... | 2021 |
Trace the full predicate network for K240821
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.