FDA 510(k)

CereLink ICP 監護器，CereLink ICP 延長線

K 號：K183406 · 2019-01-11

決定日期2019-01-11

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

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.

常見問題

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.

其他以 Integra Lifesciences Corp. 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。

K183581科德曼一次性穿釘器 K182265CodMan Certas Plus 可編程閥 K181902科德曼Certas Plus電子工具套件

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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。