Cleared Traditional

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Neurology
Jul 2024
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K240821 is an FDA 510(k) clearance for the B4C System - Addition of new sensor model (BcSs-PICNIW-2000), a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. (S?o Carlos, BR). The FDA issued a Cleared decision on July 18, 2024, 115 days after receiving the submission on March 25, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K240821 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2024
Decision Date July 18, 2024
Days to Decision 115 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

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