FDA 510(k)

DirectLink ICP模块，DirectLink ICP延长线，患者监护器接口线

K号: K152670 · 2016-01-22

决定日期2016-01-22

产品代码GWM

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决定实质等同

器械摘要

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152670. 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 DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Medos International SARL. The 510(k) number is K152670.

When did DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables receive FDA 510(k) clearance?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152670.

Who is the listed applicant for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

The FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is GWM.

列明Medos International SARL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。

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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

官方来源

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