FDA 510(k)

MPR2 logO 資料記錄器

K 號：K171666 · 2017-07-06

決定日期2017-07-06

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

MPR2 logO DATALOGGER is the device name listed in this FDA 510(k) record. The listed applicant is Raumedic AG. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171666. 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 MPR2 logO DATALOGGER?

MPR2 logO DATALOGGER is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Raumedic AG. The 510(k) number is K171666.

When did MPR2 logO DATALOGGER receive FDA 510(k) clearance?

MPR2 logO DATALOGGER received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171666.

Who is the listed applicant for MPR2 logO DATALOGGER?

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

What is the FDA product code for MPR2 logO DATALOGGER?

The FDA product code for MPR2 logO DATALOGGER is GWM.

其他以 Raumedic AG 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。

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)；BOLT

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

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