FDA 510(k)

B4C System

N.º K: K201989 · 2021-10-08

SolicitanteBraincare Desenvolvimento E Inovacao Tecnologica S.A.

Fecha de decisión2021-10-08

Código de productoGWM

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

B4C System is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K201989. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the B4C System?

B4C System is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K201989.

When did B4C System receive FDA 510(k) clearance?

B4C System received FDA 510(k) clearance on 2021-10-08, under 510(k) number K201989.

Who is the listed applicant for B4C System?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovacao Tecnologica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B4C System?

The FDA product code for B4C System is GWM.

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Otros registros que enlistan a Braincare Desenvolvimento E Inovacao Tecnologica S.A. como solicitante

K182073BcSs-PICNI-2000 Sensor

Dispositivos relacionados (Código: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AG K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc.

Fuente oficial

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