FDA 510(k)

Bravo G4 蒸汽滅菌器

K 號：K210326 · 2021-07-01

決定日期2021-07-01

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Bravo G4 Chamber Autoclave is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K210326. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bravo G4 Chamber Autoclave?

Bravo G4 Chamber Autoclave is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Scican , Ltd.. The 510(k) number is K210326.

When did Bravo G4 Chamber Autoclave receive FDA 510(k) clearance?

Bravo G4 Chamber Autoclave received FDA 510(k) clearance on 2021-07-01, under 510(k) number K210326.

Who is the listed applicant for Bravo G4 Chamber Autoclave?

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

What is the FDA product code for Bravo G4 Chamber Autoclave?

The FDA product code for Bravo G4 Chamber Autoclave is FLE.

其他以 Scican , Ltd. 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。

K214057STATIM 6000B 露膠真空滅菌器 K192910STATClave G4 蒸汽壓力殺菌器 K190062STATCLAVE G4 蒸汽壓力殺菌器 K172292SALUS - 清潔儀器再處理容器

相關器械（代碼：FLE）

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。

K261055AMSCO 700 鋰氣滅菌器STERIS Corporation K260254Enbio PROEnbio Group AG K252307Getinge GSS67N系列蒸氣滅菌器Maquet GmbH (A Getinge Group Company)K250168Life Ultra 25L 桌上單室蒸汽滅菌器Lucas Lifecare K250164卡式蒸汽滅菌器（ACA5）Guangzhou Ajax Medical Equipment Co., Ltd.K243994蒸汽滅菌器（2545D）Ningbo Ican Machines Co., Ltd.

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。