FDA 510(k)

CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）

K号: K232890 · 2024-02-04

申请人Integra Lifesciences Production Corporation

决定日期2024-02-04

产品代码GWM

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2024-02-04 under 510(k) number K232890. 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 (826820), CereLink ICP Extension Cable (826845)?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is a medical device that received FDA 510(k) clearance on 2024-02-04. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K232890.

When did CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) receive FDA 510(k) clearance?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) received FDA 510(k) clearance on 2024-02-04, under 510(k) number K232890.

Who is the listed applicant for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)?

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

What is the FDA product code for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)?

The FDA product code for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is GWM.

列明Integra Lifesciences Production Corporation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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）K243531Codman Libertís分流导管，带Bactiseal和Endexo技术 K243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus 可编程阀门

查看所有 9 个设备 →

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.K201989B4C 系统Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 监测器Integra Lifesciences Production Corporation K201118Exacta 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。