Cleared Traditional

K182073 - BcSs-PICNI-2000 Sensor
(FDA 510(k) Clearance)

K182073 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Neurology
Oct 2019
Decision
442d
Days
Class 2
Risk

K182073 is an FDA 510(k) clearance for the BcSs-PICNI-2000 Sensor, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. (Sao Carlos, BR). The FDA issued a Cleared decision on October 17, 2019, 442 days after receiving the submission on August 1, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K182073 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2018
Decision Date October 17, 2019
Days to Decision 442 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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