FDA 510(k)

Pressio 3 多參數神經監測系統

K 號：K252241 · 2026-04-10

決定日期2026-04-10

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

Pressio 3 Multi-parameter Neuromonitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252241. 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 Pressio 3 Multi-parameter Neuromonitoring System?

Pressio 3 Multi-parameter Neuromonitoring System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Sophysa. The 510(k) number is K252241.

When did Pressio 3 Multi-parameter Neuromonitoring System receive FDA 510(k) clearance?

Pressio 3 Multi-parameter Neuromonitoring System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252241.

Who is the listed applicant for Pressio 3 Multi-parameter Neuromonitoring System?

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

What is the FDA product code for Pressio 3 Multi-parameter Neuromonitoring System?

The FDA product code for Pressio 3 Multi-parameter Neuromonitoring System is GWM.

其他以 Sophysa 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。

K250636Sophy Mini 單壓力閥 (SM1)K242974外部CSF引流室內針管，外部CSF引流腰推針管 K222422極光閥電子讀取儀

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。

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 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.

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