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FDA 510(k)

HICP200 患者／監護器互連纜線

K 號：K161010 · 2016-10-20

申請人Innerspace Neuro Solutions, Inc.
決定日期2016-10-20
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

HICP200 Patient/Monitor Interconnect Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace Neuro Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161010. 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 HICP200 Patient/Monitor Interconnect Cable?

HICP200 Patient/Monitor Interconnect Cable is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Innerspace Neuro Solutions, Inc.. The 510(k) number is K161010.

When did HICP200 Patient/Monitor Interconnect Cable receive FDA 510(k) clearance?

HICP200 Patient/Monitor Interconnect Cable received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161010.

Who is the listed applicant for HICP200 Patient/Monitor Interconnect Cable?

The FDA 510(k) record lists Innerspace Neuro Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HICP200 Patient/Monitor Interconnect Cable?

The FDA product code for HICP200 Patient/Monitor Interconnect Cable is GWM.

相關臨床試驗

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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SophysaK250285NEUROVENT-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 AGK240821B4C 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 CorporationK201989B4C 系統Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 監護儀Integra Lifesciences Production Corporation

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