FDA 510(k)

BcSs-PICNI-2000 传感器

K号: K182073 · 2019-10-17

申请人Braincare Desenvolvimento E Inovacao Tecnologica S.A.

决定日期2019-10-17

产品代码GWM

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决定实质等同

器械摘要

BcSs-PICNI-2000 Sensor 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 2019-10-17 under 510(k) number K182073. 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 BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K182073.

When did BcSs-PICNI-2000 Sensor receive FDA 510(k) clearance?

BcSs-PICNI-2000 Sensor received FDA 510(k) clearance on 2019-10-17, under 510(k) number K182073.

Who is the listed applicant for BcSs-PICNI-2000 Sensor?

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 BcSs-PICNI-2000 Sensor?

The FDA product code for BcSs-PICNI-2000 Sensor is GWM.

列明Braincare Desenvolvimento E Inovacao Tecnologica S.A.为申报人的其他记录

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。

K201989B4C 系统

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Sophysa 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 系统 - 新增传感器型号（BcSs-PICNIW-2000）Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）Integra Lifesciences Production Corporation K201989B4C 系统Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 监测器Integra Lifesciences Production Corporation

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