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FDA 510(k)

B4C 系统 - 新增传感器型号（BcSs-PICNIW-2000）

K号: K240821 · 2024-07-18

申请人Braincare Desenvolvimento E Inovação Tecnológica S.A.
决定日期2024-07-18
产品代码GWM
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决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GWM）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252241Pressio 3多参数神经监测系统SophysaK250285NEUROVENT-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 AGK232890CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）Integra Lifesciences Production CorporationK201989B4C 系统Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 监测器Integra Lifesciences Production CorporationK201118Exacta 外部引流和监控系统，Exacta 激光水平仪支架，Exacta 系统更换引流袋，更换激光水平仪Medtronic, Inc.

官方来源

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