FDA 510(k)

DirectLink ICP 模組、DirectLink ICP 延長線、病人監護器介面纜線

K 號：K152670 · 2016-01-22

決定日期2016-01-22

產品代碼GWM

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Medos International SARL 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254157CROSSNAV 體外預處理及間體植入器導航設備 K260240和諧導航準備儀器 K253249TriALTIS™脊椎系統 K243249TriALTIS™脊椎系統 K241893CROSSNAV導航啟用儀器和UNAS導航陣列 K242042TriALTIS™脊椎系統

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相關器械（代碼：GWM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252241Pressio 3 多參數神經監測系統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)；BOLTRaumedic AG K240821B4C 系統 - 新增感測器型號 (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP 監護器（826820），CereLink ICP 延長線（826845）Integra Lifesciences Production Corporation K201989B4C 系統Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 監護儀Integra Lifesciences Production Corporation

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