FDA 510(k)

CereLink ICP 监测仪，CereLink ICP 延长线

K号: K183406 · 2019-01-11

决定日期2019-01-11

产品代码GWM

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决定实质等同

器械摘要

CereLink ICP Monitor, CereLink ICP Extension Cable is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K183406. 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 CereLink ICP Monitor, CereLink ICP Extension Cable?

CereLink ICP Monitor, CereLink ICP Extension Cable is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K183406.

When did CereLink ICP Monitor, CereLink ICP Extension Cable receive FDA 510(k) clearance?

CereLink ICP Monitor, CereLink ICP Extension Cable received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183406.

Who is the listed applicant for CereLink ICP Monitor, CereLink ICP Extension Cable?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable?

The FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable is GWM.

列明Integra Lifesciences Corp.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。

K183581Codman一次性穿孔器 K182265CodMan Certas Plus可编程阀门 K181902Codman Certas Plus电子工具包

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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