FDA 510(k)

BcSs-PICNI-2000 感測器

K 號：K182073 · 2019-10-17

申請人Braincare Desenvolvimento E Inovacao Tecnologica S.A.

決定日期2019-10-17

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

BcSs-PICNI-2000 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K182073. 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 BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K182073.

When did BcSs-PICNI-2000 Sensor receive FDA 510(k) clearance?

BcSs-PICNI-2000 Sensor received FDA 510(k) clearance on 2019-10-17, under 510(k) number K182073.

Who is the listed applicant for BcSs-PICNI-2000 Sensor?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovacao Tecnologica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BcSs-PICNI-2000 Sensor?

The FDA product code for BcSs-PICNI-2000 Sensor is GWM.

其他以 Braincare Desenvolvimento E Inovacao Tecnologica S.A. 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。

K201989B4C 系統

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。