FDA 510(k)

CereLink ICP 監護儀

K 號：K210993 · 2021-04-30

申請人Integra Lifesciences Production Corporation

決定日期2021-04-30

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 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 2021-04-30 under 510(k) number K210993. 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 Monitor is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K210993.

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

CereLink ICP Monitor received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210993.

Who is the listed applicant for CereLink ICP Monitor?

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?

The FDA product code for CereLink ICP Monitor is GWM.

其他以 Integra Lifesciences Production Corporation 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。

K261004Codman® 遠端腹膜針管，铍白開口型（82-1682）；Codman® HOLTER® 腹膜針管（SALMON設計）（82-1684）K243531科德曼Libertís分流針管搭配Bactiseal及Endexo技術 K243552Codman Libertís™ 1.5 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821761）；Codman Libertís™ 1.9 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821762）K232890CereLink ICP 監護器（826820），CereLink ICP 延長線（826845）K233445Bactiseal 管腔內視鏡導管；Bactiseal 銀條條紋導管；Bactiseal 結腦室導管 K233448Bactiseal EVD 腔道針組合；Bactiseal 清晰 EVD 腔道針組合

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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.K201118Exacta 外引流及監控系統，Exacta 激光水平儀立柱，Exacta 系統替換引流袋，替換激光水平儀Medtronic, Inc.

官方來源

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