FDA 510(k)

氣球 BS-3

K 號：K213195 · 2021-10-29

決定日期2021-10-29

產品代碼FDA

諮詢委員會GU

決定相當於

器材摘要

Balloon BS-3 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213195. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Balloon BS-3?

Balloon BS-3 is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Fujifilm Corporation. The 510(k) number is K213195.

When did Balloon BS-3 receive FDA 510(k) clearance?

Balloon BS-3 received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213195.

Who is the listed applicant for Balloon BS-3?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Balloon BS-3?

The FDA product code for Balloon BS-3 is FDA.

其他以 Fujifilm 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。

K261229SCENARIA 觀察階段 6.0 K261283APERTO Lucent MRI 系統 K253836FCT iStream 階段 2 K261170BA-004CC K260567EW10-EC02內視鏡輔助程序 K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01

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相關器械（代碼：FDA）

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。

K260314Ancora-SBAspero Medical, Inc.K251204富士通 stiffening wire device (SW-2000)FUJIFILM Healthcare Americas Corporation K233321雙球囊內視鏡 EN-840T，超管 TS-1214CFUJIFILM Healthcare Americas Corporation K231323Ancora-SBAspero Medical, Inc.K223295內視鏡型號 EN-580T，過管 TS-1314B，氣球 BS-4，管套組 TY-500DFujifilm Corporaton K191330Arc EnterocuffBoddingtons Plastics, Ltd.

官方來源

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