FDA 510(k)

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

Номер K: K240821 · 2024-07-18

ЗаявительBraincare Desenvolvimento E Inovação Tecnológica S.A.

Дата решения2024-07-18

Код продуктаGWM

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovação Tecnológica S.A.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K240821. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Braincare Desenvolvimento E Inovação Tecnológica S.A.. The 510(k) number is K240821.

When did B4C System - Addition of new sensor model (BcSs-PICNIW-2000) receive FDA 510(k) clearance?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K240821.

Who is the listed applicant for B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

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

What is the FDA product code for B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

The FDA product code for B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is GWM.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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 K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.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.

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